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    Clinical Trial Results:
    A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)

    Summary
    EudraCT number
    		 2017-005047-32
    Trial protocol
    		 DK   BE   FR   AT   NO   DE   NL  
    Global end of trial date
    22 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2023
    First version publication date
    08 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H-100-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03629080
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hookipa Biotech GmbH
    Sponsor organisation address
    Helmut-Qualtinger-Gasse 2, Vienna, Austria, 1030
    Public contact
    General Contact, Hookipa Biotech GmbH, +43 18906360, office@hookipapharma.com
    Scientific contact
    General Contact, Hookipa Biotech GmbH, +43 18906360, office@hookipapharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 May 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1.To assess the safety and reactogenicity of HB-101. 2.To assess the immunogenicity of HB-101.
    Protection of trial subjects
    All considerations regarding the protection of human subjects were carried out in accordance with the protocol, GCP, ICH Guidelines, the ethical principles that have their origin in the Declaration of Helsinki, and all applicable regulatory requirements. The investigator (according to applicable regulatory requirements) or a person designated by the investigator and under the investigator’s responsibility fully informed patients of all pertinent aspects of the clinical trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 50
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Germany: 6
    Worldwide total number of subjects
    83
    EEA total number of subjects
    19
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    71
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall, 90 patients were screened. Seven (7.8%) patients were screen-failed and 83 (92.2%) were subsequently randomized/enrolled. The reasons for screen failure were withdrawal by patient (4 [4.4%] patients), failure to meet inclusion/exclusion criteria (2 [2.2%] patients), and other (1 [1.1%]. The study was conducted at 26 global sites.

    Pre-assignment
    Screening details
    		 Male and female patients 18 years of age or older who were eligible to undergo kidney transplantation from a living donor. Groups 1 and 2: CMV immunoglobulin G (IgG) seronegative (-) patients receiving a kidney from CMV IgG seropositive (+) donors. Group 3: CMV IgG (+) patients receiving a kidney from CMV IgG (+) or CMV IgG (-) donors.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The study was double-blinded for Groups 1 and 2; patients and Investigators were blinded to study treatment. The Sponsor study team members were unblinded after each patient received their last dose of study drug and underwent his/her kidney transplantation. Medpace, the Investigator, and study site personnel remained blinded for the entire study with the exception of the study site pharmacist who prepared the study drug for administration. Group 3 was open label; no randomization or blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Arm 1a: HB-101 vaccine preemptive
    Arm description
    		 Group 1: The preemptive group (CMV seronegative) was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients were monitored per preemptive institutional standards. Arm 1a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive HB-101 before transplant, and monitoring after transplant. Three intramuscular doses of study drug were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HB-101
    Investigational medicinal product code
    HK1-HgB and HK1-Hpp65
    Other name
    rLCMV vector (HK1) encoding human CMV glycoprotein B (gB) and phosphoprotein 65 kD (Hpp65)
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HB-101 uses replication-deficient lymphocytic choriomeningitis virus (rLCMV) as a vector for a bivalent recombinant vaccine against human cytomegalovirus (HCMV). One vector expresses the pp65 protein of HCMV, and one expresses a truncated gB protein of HCMV. HB-101 was produced pre-diluted and ready-to-use. HB-101 is formulated at 1.2 E8 focus-forming units/mL. The product is filled in 2 mL single-dose vials containing 0.7 mL of vaccine. The volume of administration of 1 dose of HB-101 is 1.0 mL. Three intramuscular doses of study drug were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. Patients enrolled had to have a kidney transplantation planned between 2 and 4 months after the first injection of study drug. This was to ensure that patients received at least 2 doses of HB-101.

    Arm title
    		 Group 1: Arm 1b: Placebo preemptive
    Arm description
    		 Group 1: The preemptive group (CMV seronegative) was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients were monitored per preemptive institutional standards. Arm 1b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive placebo before transplant, and monitoring after transplant. Three intramuscular doses of placebo were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Saline (0.9% w/v NaCl) as a ready-to-use solution for intramuscular injection was used as the placebo. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. Patients enrolled had to have a kidney transplantation planned between 2 and 4 months after the first injection of the placebo.

    Arm title
    		 Group 2: Arm 2a: HB-101 vaccine prophylactic
    Arm description
    		 Group 2 - The prophylactic group was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients received 3 to 6 months of anti-viral prophylaxis following institutional standards. Arm 2a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive HB-101 before transplant, and anti-viral prophylaxis and monitoring after transplant. Three intramuscular doses of study drug were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HB-101
    Investigational medicinal product code
    HK1-HgB and HK1-Hpp65
    Other name
    rLCMV vector (HK1) encoding human CMV glycoprotein B (gB) and phosphoprotein 65 kD (Hpp65)
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HB-101 uses replication-deficient lymphocytic choriomeningitis virus (rLCMV) as a vector for a bivalent recombinant vaccine against human cytomegalovirus (HCMV). One vector expresses the pp65 protein of HCMV, and one expresses a truncated gB protein of HCMV. HB-101 was produced pre-diluted and ready-to-use. HB-101 is formulated at 1.2 E8 focus-forming units/mL. The product is filled in 2 mL single-dose vials containing 0.7 mL of vaccine. The volume of administration of 1 dose of HB-101 is 1.0 mL. Three intramuscular doses of study drug were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. Patients enrolled had to have a kidney transplantation planned between 2 and 4 months after the first injection of study drug. This was to ensure that patients received at least 2 doses of HB-101.

    Arm title
    		 Group 2: Arm 2b: Placebo prophylactic
    Arm description
    		 Group 2 - The prophylactic group was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients received 3 to 6 months of anti-viral prophylaxis following institutional standards. Arm 2b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive placebo before transplant, and anti-viral prophylaxis and monitoring after transplant. Three intramuscular doses of placebo were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Saline (0.9% w/v NaCl) as a ready-to-use solution for intramuscular injection was used as the placebo. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. Patients enrolled had to have a kidney transplantation planned between 2 and 4 months after the first injection of the placebo.

    Arm title
    		 Group 3: HB-101 vaccine: CMV (+) patients: preemptive
    Arm description
    		 Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant CMV management followed preemptive care as defined at study enrollment by the Investigator and institutional standards. The ITT Population included all patients who were enrolled in the study. For Group 3, enrollment was defined as receiving at least 1 dose of study drug. The mITT Population included all ITT Population patients who received a kidney transplant and at least 2 doses of study drug prior to kidney transplant. For this arm, “study completion” means that the patient was included in the mITT Population.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HB-101
    Investigational medicinal product code
    HK1-HgB and HK1-Hpp65
    Other name
    rLCMV vector (HK1) encoding human CMV glycoprotein B (gB) and phosphoprotein 65 kD (Hpp65)
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HB-101 uses replication-deficient lymphocytic choriomeningitis virus (rLCMV) as a vector for a bivalent recombinant vaccine against human cytomegalovirus (HCMV). One vector expresses the pp65 protein of HCMV, and one expresses a truncated gB protein of HCMV. HB-101 was produced pre-diluted and ready-to-use. HB-101 is formulated at 1.2 E8 focus-forming units/mL. The product is filled in 2 mL single-dose vials containing 0.7 mL of vaccine. The volume of administration of 1 dose of HB-101 is 1.0 mL. Three intramuscular doses of study drug were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. Patients enrolled had to have a kidney transplantation planned between 2 and 4 months after the first injection of study drug. This was to ensure that patients received at least 2 doses of HB-101.

    Arm title
    		 Group 3: HB-101 vaccine: CMV (+) patients: prophylactic
    Arm description
    		 Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant patients received anti-viral prophylaxis following institutional standards. The ITT Population included all patients who were enrolled in the study. For Group 3, enrollment was defined as receiving at least 1 dose of study drug. The mITT Population included all ITT Population patients who received a kidney transplant and at least 2 doses of study drug prior to kidney transplant. For this arm, “study completion” means that the patient was included in the mITT Population.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HB-101
    Investigational medicinal product code
    HK1-HgB and HK1-Hpp65
    Other name
    rLCMV vector (HK1) encoding human CMV glycoprotein B (gB) and phosphoprotein 65 kD (Hpp65)
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HB-101 uses replication-deficient lymphocytic choriomeningitis virus (rLCMV) as a vector for a bivalent recombinant vaccine against human cytomegalovirus (HCMV). One vector expresses the pp65 protein of HCMV, and one expresses a truncated gB protein of HCMV. HB-101 was produced pre-diluted and ready-to-use. HB-101 is formulated at 1.2 E8 focus-forming units/mL. The product is filled in 2 mL single-dose vials containing 0.7 mL of vaccine. The volume of administration of 1 dose of HB-101 is 1.0 mL. Three intramuscular doses of study drug were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. Patients enrolled had to have a kidney transplantation planned between 2 and 4 months after the first injection of study drug. This was to ensure that patients received at least 2 doses of HB-101.

    Number of subjects in period 1
    		Group 1: Arm 1a: HB-101 vaccine preemptive Group 1: Arm 1b: Placebo preemptive Group 2: Arm 2a: HB-101 vaccine prophylactic Group 2: Arm 2b: Placebo prophylactic Group 3: HB-101 vaccine: CMV (+) patients: preemptive Group 3: HB-101 vaccine: CMV (+) patients: prophylactic
    Started
    12
    5
    35
    17
    4
    10
    Completed
    10
    4
    22
    16
    3
    6
    Not completed
    2
    1
    13
    1
    1
    4
         Adverse event, serious fatal
    -
    -
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    1
    2
    1
    -
    -
         Physician decision
    -
    -
    1
    -
    -
    -
         Kidney transplant was delayed
    -
    -
    3
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    1
    -
    -
    -
         Kidney transplant was delayed
    -
    -
    -
    -
    1
    3
         Other
    1
    -
    2
    -
    -
    -
         Did not receive at least 2 doses of study drug
    -
    -
    -
    -
    -
    1
         Failure to comply with Protocol requirements
    1
    -
    1
    -
    -
    -
         Lost to follow-up
    -
    -
    2
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Arm 1a: HB-101 vaccine preemptive
    Reporting group description
    		 Group 1: The preemptive group (CMV seronegative) was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients were monitored per preemptive institutional standards. Arm 1a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive HB-101 before transplant, and monitoring after transplant. Three intramuscular doses of study drug were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.

    Reporting group title
    Group 1: Arm 1b: Placebo preemptive
    Reporting group description
    		 Group 1: The preemptive group (CMV seronegative) was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients were monitored per preemptive institutional standards. Arm 1b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive placebo before transplant, and monitoring after transplant. Three intramuscular doses of placebo were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.

    Reporting group title
    Group 2: Arm 2a: HB-101 vaccine prophylactic
    Reporting group description
    		 Group 2 - The prophylactic group was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients received 3 to 6 months of anti-viral prophylaxis following institutional standards. Arm 2a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive HB-101 before transplant, and anti-viral prophylaxis and monitoring after transplant. Three intramuscular doses of study drug were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.

    Reporting group title
    Group 2: Arm 2b: Placebo prophylactic
    Reporting group description
    		 Group 2 - The prophylactic group was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients received 3 to 6 months of anti-viral prophylaxis following institutional standards. Arm 2b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive placebo before transplant, and anti-viral prophylaxis and monitoring after transplant. Three intramuscular doses of placebo were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.

    Reporting group title
    Group 3: HB-101 vaccine: CMV (+) patients: preemptive
    Reporting group description
    		 Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant CMV management followed preemptive care as defined at study enrollment by the Investigator and institutional standards. The ITT Population included all patients who were enrolled in the study. For Group 3, enrollment was defined as receiving at least 1 dose of study drug. The mITT Population included all ITT Population patients who received a kidney transplant and at least 2 doses of study drug prior to kidney transplant. For this arm, “study completion” means that the patient was included in the mITT Population.

    Reporting group title
    Group 3: HB-101 vaccine: CMV (+) patients: prophylactic
    Reporting group description
    		 Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant patients received anti-viral prophylaxis following institutional standards. The ITT Population included all patients who were enrolled in the study. For Group 3, enrollment was defined as receiving at least 1 dose of study drug. The mITT Population included all ITT Population patients who received a kidney transplant and at least 2 doses of study drug prior to kidney transplant. For this arm, “study completion” means that the patient was included in the mITT Population.

    Reporting group values
    		 Group 1: Arm 1a: HB-101 vaccine preemptive Group 1: Arm 1b: Placebo preemptive Group 2: Arm 2a: HB-101 vaccine prophylactic Group 2: Arm 2b: Placebo prophylactic Group 3: HB-101 vaccine: CMV (+) patients: preemptive Group 3: HB-101 vaccine: CMV (+) patients: prophylactic Total
    Number of subjects
    		 12 5 35 17 4 10 83
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 9 2 31 16 4 9 71
        From 65-84 years
    		 3 3 4 1 0 1 12
        85 years and over
    		 0 0 0 0 0 0 0
    Age continuous
    ITT Population: For the 47 patients randomized to HB-101 in Groups 1 and 2, the mean age (standard deviation [SD]) was 47.4 (14.97) years with a minimum of 20 and a maximum of 70 years. Of the 22 patients randomized to placebo in Groups 1 and 2, the mean age (SD) was 49.6 (15.04) years with a minimum of 24 and a maximum of 72 years. For the 14 patients in Group 3, the mean age (SD) was 49.1 (10.49) years with a minimum of 35 and a maximum of 69 years.
    Units: years
        arithmetic mean (standard deviation)
    		 47.5 ( 15.17 ) 63.6 ( 9.45 ) 47.3 ( 15.13 ) 45.5 ( 13.99 ) 48.3 ( 6.99 ) 49.5 ( 11.92 ) -
    Gender categorical
    ITT Population: Of the 47 patients randomized to HB-101 in Groups 1 and 2, 37 (78.7%) were male and 10 (21.3%) were female. Of the 22 patients randomized to placebo in Groups 1 and 2, 16 (72.7%) were male and 6 (27.3%) were female. Of the 14 patients in Group 3, 10 (71.4%) were male and 4 (28.6%) were female.
    Units: Subjects
        Female
    		 4 0 6 6 1 7 24
        Male
    		 8 5 29 11 3 3 59
    Subject analysis sets

    Subject analysis set title
    Safety Population Arm 1a: HB-101: Preemptive
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 1a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive HB-101 before transplant, and monitoring after transplant.

    Subject analysis set title
    Safety Population Arm 2a: HB-101: Prophylactic
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 2a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive HB-101 before transplant, and anti-viral prophylaxis and monitoring after transplant.

    Subject analysis set title
    Safety Population Arm 1b: Placebo: Preemptive
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 1b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive placebo before transplant, and monitoring after transplant.

    Subject analysis set title
    Safety Population Arm 2b: Placebo: Prophylactic
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 2b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive placebo before transplant, and anti-viral prophylaxis and monitoring after transplant.

    Subject analysis set title
    Safety Population Group 3: HB-101: CMV (+): Preemptive
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant CMV management followed preemptive care as defined at study enrollment by the Investigator and institutional standards.

    Subject analysis set title
    Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant patients received anti-viral prophylaxis following institutional standards.

    Subject analysis set title
    Immunogenicity Population Arm 1a: HB-101: Preemptive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all ITT Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Arm 1a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive HB-101 before transplant, and monitoring after transplant.

    Subject analysis set title
    Immunogenicity Population Arm 1b: Placebo: Preemptive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all Intent-to-Treat (ITT) Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Arm 1b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive placebo before transplant, and monitoring after transplant.

    Subject analysis set title
    Immunogenicity Population Arm 2a: HB-101: Prophylactic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all Intent-to-Treat (ITT) Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Arm 2a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive HB-101 before transplant, and anti-viral prophylaxis and monitoring after transplant.

    Subject analysis set title
    Immunogenicity Population Arm 2b: Placebo: Prophylactic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all Intent-to-Treat (ITT) Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Arm 2b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive placebo before transplant, and anti-viral prophylaxis and monitoring after transplant.

    Subject analysis set title
    Immunogenicity Population Group 3: HB-101: CMV (+) preemptive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all Intent-to-Treat (ITT) Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant CMV management followed preemptive care as defined at study enrollment by the Investigator and institutional standards.

    Subject analysis set title
    Immunogenicity Population Group 3 HB-101: CMV (+) Prophylactic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all Intent-to-Treat (ITT) Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant patients received anti-viral prophylaxis following institutional standards.

    Subject analysis sets values
    		 Safety Population Arm 1a: HB-101: Preemptive Safety Population Arm 2a: HB-101: Prophylactic Safety Population Arm 1b: Placebo: Preemptive Safety Population Arm 2b: Placebo: Prophylactic Safety Population Group 3: HB-101: CMV (+): Preemptive Safety Population Group 3: HB-101: CMV (+): Prophylactic Immunogenicity Population Arm 1a: HB-101: Preemptive Immunogenicity Population Arm 1b: Placebo: Preemptive Immunogenicity Population Arm 2a: HB-101: Prophylactic Immunogenicity Population Arm 2b: Placebo: Prophylactic Immunogenicity Population Group 3: HB-101: CMV (+) preemptive Immunogenicity Population Group 3 HB-101: CMV (+) Prophylactic
    Number of subjects
    11
    34
    4
    17
    4
    10
    11
    4
    27
    13
    3
    8
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    8
    30
    1
    16
    4
    9
    9
    1
    25
    12
    3
    7
        From 65-84 years
    3
    4
    3
    1
    0
    1
    2
    3
    2
    1
    0
    1
        85 years and over
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Age continuous
    ITT Population: For the 47 patients randomized to HB-101 in Groups 1 and 2, the mean age (standard deviation [SD]) was 47.4 (14.97) years with a minimum of 20 and a maximum of 70 years. Of the 22 patients randomized to placebo in Groups 1 and 2, the mean age (SD) was 49.6 (15.04) years with a minimum of 24 and a maximum of 72 years. For the 14 patients in Group 3, the mean age (SD) was 49.1 (10.49) years with a minimum of 35 and a maximum of 69 years.
    Units: years
        arithmetic mean (standard deviation)
    46.90 ( 15.76 )
    47.08 ( 15.29 )
    66.25 ( 8.26 )
    45.82 ( 14.05 )
    48.25 ( 6.99 )
    49.50 ( 11.91 )
    45.72 ( 14.55 )
    65.50 ( 9.74 )
    44.66 ( 15.62 )
    48.38 ( 13.90 )
    49.33 ( 8.14 )
    51.00 ( 12.21 )
    Gender categorical
    ITT Population: Of the 47 patients randomized to HB-101 in Groups 1 and 2, 37 (78.7%) were male and 10 (21.3%) were female. Of the 22 patients randomized to placebo in Groups 1 and 2, 16 (72.7%) were male and 6 (27.3%) were female. Of the 14 patients in Group 3, 10 (71.4%) were male and 4 (28.6%) were female.
    Units: Subjects
        Female
    3
    6
    1
    6
    1
    3
    4
    0
    4
    5
    1
    3
        Male
    8
    28
    3
    11
    3
    7
    7
    4
    23
    8
    2
    5

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Arm 1a: HB-101 vaccine preemptive
    Reporting group description
    		 Group 1: The preemptive group (CMV seronegative) was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients were monitored per preemptive institutional standards. Arm 1a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive HB-101 before transplant, and monitoring after transplant. Three intramuscular doses of study drug were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.

    Reporting group title
    Group 1: Arm 1b: Placebo preemptive
    Reporting group description
    		 Group 1: The preemptive group (CMV seronegative) was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients were monitored per preemptive institutional standards. Arm 1b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive placebo before transplant, and monitoring after transplant. Three intramuscular doses of placebo were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.

    Reporting group title
    Group 2: Arm 2a: HB-101 vaccine prophylactic
    Reporting group description
    		 Group 2 - The prophylactic group was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients received 3 to 6 months of anti-viral prophylaxis following institutional standards. Arm 2a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive HB-101 before transplant, and anti-viral prophylaxis and monitoring after transplant. Three intramuscular doses of study drug were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.

    Reporting group title
    Group 2: Arm 2b: Placebo prophylactic
    Reporting group description
    		 Group 2 - The prophylactic group was randomized in a 2:1 ratio (HB-101:placebo) to receive either HB-101 or placebo before transplant. Post-transplant patients received 3 to 6 months of anti-viral prophylaxis following institutional standards. Arm 2b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive placebo before transplant, and anti-viral prophylaxis and monitoring after transplant. Three intramuscular doses of placebo were to be administered. The ideal dosing schedule for the 3 doses was planned for 0, 1, and 3 months prior to kidney transplant. The Intent-to-Treat (ITT) Population includes all patients who were enrolled. For Group 1 and Group 2, enrolled is defined as being randomized and patients were analyzed by their randomized treatment group.

    Reporting group title
    Group 3: HB-101 vaccine: CMV (+) patients: preemptive
    Reporting group description
    		 Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant CMV management followed preemptive care as defined at study enrollment by the Investigator and institutional standards. The ITT Population included all patients who were enrolled in the study. For Group 3, enrollment was defined as receiving at least 1 dose of study drug. The mITT Population included all ITT Population patients who received a kidney transplant and at least 2 doses of study drug prior to kidney transplant. For this arm, “study completion” means that the patient was included in the mITT Population.

    Reporting group title
    Group 3: HB-101 vaccine: CMV (+) patients: prophylactic
    Reporting group description
    		 Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant patients received anti-viral prophylaxis following institutional standards. The ITT Population included all patients who were enrolled in the study. For Group 3, enrollment was defined as receiving at least 1 dose of study drug. The mITT Population included all ITT Population patients who received a kidney transplant and at least 2 doses of study drug prior to kidney transplant. For this arm, “study completion” means that the patient was included in the mITT Population.

    Subject analysis set title
    Safety Population Arm 1a: HB-101: Preemptive
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 1a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive HB-101 before transplant, and monitoring after transplant.

    Subject analysis set title
    Safety Population Arm 2a: HB-101: Prophylactic
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 2a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive HB-101 before transplant, and anti-viral prophylaxis and monitoring after transplant.

    Subject analysis set title
    Safety Population Arm 1b: Placebo: Preemptive
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 1b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive placebo before transplant, and monitoring after transplant.

    Subject analysis set title
    Safety Population Arm 2b: Placebo: Prophylactic
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 2b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive placebo before transplant, and anti-viral prophylaxis and monitoring after transplant.

    Subject analysis set title
    Safety Population Group 3: HB-101: CMV (+): Preemptive
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant CMV management followed preemptive care as defined at study enrollment by the Investigator and institutional standards.

    Subject analysis set title
    Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant patients received anti-viral prophylaxis following institutional standards.

    Subject analysis set title
    Immunogenicity Population Arm 1a: HB-101: Preemptive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all ITT Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Arm 1a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive HB-101 before transplant, and monitoring after transplant.

    Subject analysis set title
    Immunogenicity Population Arm 1b: Placebo: Preemptive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all Intent-to-Treat (ITT) Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Arm 1b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive placebo before transplant, and monitoring after transplant.

    Subject analysis set title
    Immunogenicity Population Arm 2a: HB-101: Prophylactic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all Intent-to-Treat (ITT) Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Arm 2a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive HB-101 before transplant, and anti-viral prophylaxis and monitoring after transplant.

    Subject analysis set title
    Immunogenicity Population Arm 2b: Placebo: Prophylactic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all Intent-to-Treat (ITT) Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Arm 2b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive placebo before transplant, and anti-viral prophylaxis and monitoring after transplant.

    Subject analysis set title
    Immunogenicity Population Group 3: HB-101: CMV (+) preemptive
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all Intent-to-Treat (ITT) Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant CMV management followed preemptive care as defined at study enrollment by the Investigator and institutional standards.

    Subject analysis set title
    Immunogenicity Population Group 3 HB-101: CMV (+) Prophylactic
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The Immunogenicity Population included all Intent-to-Treat (ITT) Population patients who received at least 1 dose of study drug and who had at least 1 post-dose immunogenicity measurement. Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant patients received anti-viral prophylaxis following institutional standards.

    Primary: Safety: Incidence and severity of AEs and SAEs

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    End point title
    		 Safety: Incidence and severity of AEs and SAEs [1]
    End point description
    Groups 1 and 2: Overall, 42 (63.6%) patients reported AEs during the pre-transplant period. Overall, 13 (19.7%) patients experienced a TEAE related to study drug pre-transplant and 2 (3.0%) patients experienced TEAEs related to study drug of Grade 3 or higher. Overall, 29 (64.4%) patients in the HB-101 treatment group reported TEAEs post-transplant: 6 (54.5%) patients who received preemptive care and 23 (67.6%) patients who received prophylactic treatment. There were 19 (42.2%) patients in the HB-101 treatment group who experienced SAEs and 19 (42.2%) patients who experienced treatment-emergent SAEs. Group 3: Overall, 8 (57.1%) patients reported AEs and 3 (21.4%) patients experienced a TEAE related to study drug during the pre-transplant period. Overall, 9 (64.3%) patients reported TEAEs post-transplant: 3 (75.0%) patients who received preemptive care and 6 (60.0%) patients who received prophylactic treatment.
    End point type
    Primary
    End point timeframe
    Adverse events (AEs) were captured from the date of informed consent through study completion (15 months).A treatment-emergent AE (TEAE) was defined as an AE with a start date and time on or after the first administration of study drug.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Safety assessments were were summarized by descriptive statistics. However, AEs were captured from the date of informed consent through study completion. All AEs were coded to SOC and PT using the MedDRA version 22.0 and analyzed using the Safety Population. This information can be found in the "Adverse Events" section.
    End point values
    		 Safety Population Arm 1a: HB-101: Preemptive Safety Population Arm 2a: HB-101: Prophylactic Safety Population Arm 1b: Placebo: Preemptive Safety Population Arm 2b: Placebo: Prophylactic Safety Population Group 3: HB-101: CMV (+): Preemptive Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Number of subjects analysed
    11
    34
    4
    17
    4
    10
    Units: patients
    11
    34
    4
    17
    4
    10
    No statistical analyses for this end point

    Primary: Safety: Body temperature

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    End point title
    		 Safety: Body temperature [2]
    End point description
    Oral body temperature was measured in degrees Celsius prior to study drug administrations and seven days after. RESULTS: The results express the change from baseline to Dose 3. There were no clinically meaningful changes in the median values for body temperature assessment from baseline.
    End point type
    Primary
    End point timeframe
    Change from Baseline to Dose 3. Three (3) months.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Vital signs including height, weight, systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature were summarized by descriptive statistics for each treatment group.
    End point values
    		 Safety Population Arm 1a: HB-101: Preemptive Safety Population Arm 2a: HB-101: Prophylactic Safety Population Arm 1b: Placebo: Preemptive Safety Population Arm 2b: Placebo: Prophylactic Safety Population Group 3: HB-101: CMV (+): Preemptive Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Number of subjects analysed
    3
    12
    1
    7
    2
    1
    Units: celsius temperature
        arithmetic mean (standard deviation)
    -0.0 ( 0.4 )
    0.2 ( 0.6 )
    -0.1 ( 0.0 )
    -0.3 ( 0.26 )
    -0.2 ( 0.57 )
    0.6 ( 0.0 )
    No statistical analyses for this end point

    Primary: Safety: Respiratory rate

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    End point title
    		 Safety: Respiratory rate [3]
    End point description
    Respiration rate in breaths per minute was measured prior to study drug administration and seven days after. RESULTS: The results express the change from baseline to Dose 3. There were no clinically meaningful changes in the median values for respiratory rate assessment from baseline.
    End point type
    Primary
    End point timeframe
    Change from Baseline to Dose 3. Three (3) months.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Vital signs including height, weight, systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature were summarized by descriptive statistics for each treatment group.
    End point values
    		 Safety Population Arm 1a: HB-101: Preemptive Safety Population Arm 2a: HB-101: Prophylactic Safety Population Arm 1b: Placebo: Preemptive Safety Population Arm 2b: Placebo: Prophylactic Safety Population Group 3: HB-101: CMV (+): Preemptive Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Number of subjects analysed
    4
    11
    1
    7
    2
    1
    Units: breaths/minute
        arithmetic mean (standard deviation)
    0.5 ( 5.26 )
    0.2 ( 2.56 )
    0.0 ( 0.0 )
    -0.6 ( 2.70 )
    -4.0 ( 8.49 )
    2.0 ( 0.0 )
    No statistical analyses for this end point

    Primary: Safety: Diastolic blood pressure

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    End point title
    		 Safety: Diastolic blood pressure [4]
    End point description
    Diastolic Blood Pressure was measured in millimeters of mercury (mmHg) prior to study drug administration and seven days after. RESULTS: There were no clinically meaningful changes in the median values for diastolic or systolic blood pressure assessments from baseline.
    End point type
    Primary
    End point timeframe
    Change from Baseline to Dose 3. Three (3) months.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Vital signs including height, weight, systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature were summarized by descriptive statistics for each treatment group.
    End point values
    		 Safety Population Arm 1a: HB-101: Preemptive Safety Population Arm 2a: HB-101: Prophylactic Safety Population Arm 1b: Placebo: Preemptive Safety Population Arm 2b: Placebo: Prophylactic Safety Population Group 3: HB-101: CMV (+): Preemptive Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Number of subjects analysed
    4
    13
    1
    7
    2
    1
    Units: mmHg
        arithmetic mean (standard deviation)
    0.5 ( 5.74 )
    2.6 ( 9.55 )
    2.0 ( 0.0 )
    1.3 ( 6.47 )
    6.0 ( 0.0 )
    6.0 ( 0.0 )
    No statistical analyses for this end point

    Primary: Safety: Systolic Blood Pressure

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    End point title
    		 Safety: Systolic Blood Pressure [5]
    End point description
    Systolic Blood Pressure was measured in millimeters of mercury (mmHg) prior to study drug administration and seven days after. RESULTS: The results express the change from baseline to Dose 3. There were no clinically meaningful changes in the median values for systolic blood pressure assessments from baseline.
    End point type
    Primary
    End point timeframe
    Change from Baseline to Dose 3. Three (3) months.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Vital signs including height, weight, systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature were summarized by descriptive statistics for each treatment group.
    End point values
    		 Safety Population Arm 1a: HB-101: Preemptive Safety Population Arm 2a: HB-101: Prophylactic Safety Population Arm 1b: Placebo: Preemptive Safety Population Arm 2b: Placebo: Prophylactic Safety Population Group 3: HB-101: CMV (+): Preemptive Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Number of subjects analysed
    4
    13
    1
    7
    2
    1
    Units: mmHg
        arithmetic mean (standard deviation)
    -5.5 ( 12.61 )
    5.4 ( 14.36 )
    11.0 ( 0.0 )
    2.7 ( 19.81 )
    2.0 ( 2.83 )
    5.0 ( 0.0 )
    No statistical analyses for this end point

    Primary: CMV neutralizing antibody titers (NTAs) at day of Transplant for 2 doses

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    End point title
    		 CMV neutralizing antibody titers (NTAs) at day of Transplant for 2 doses [6]
    End point description
    GMT=geometric mean titer (defined as the antilog10 of the mean of log10 values). The CMV neut parameter underwent all tests and summaries of the other parameters with the addition of a 95% confidence interval of the geometric mean titer. Overall, 12 patients treated with HB-101 had positive CMV titers on the day of transplant: 2 (33.3%) patients who received 2 doses of HB-101 and preemptive care; 1 (50.0%) patient who received 3 doses of HB-101 and preemptive care; 4 (26.7%) patients who received 2 doses of HB-101 and prophylactic treatment; and 5 (100.0%) patients who received 3 doses of HB-101 and prophylactic treatment. Compared to placebo, more patients treated with HB-101 had positive CMV titers on the day of transplant. Patients who received 3 doses of HB-101 and prophylactic treatment had statistically significant higher CMV titers compared to placebo (p=0.0022) on the day of transplant.
    End point type
    Primary
    End point timeframe
    Day of transplant. Three (3) months.
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: CMV neutralizing antibody titers (NTAs) at day of transplant for 2 doses were summarized by descriptive statistics for each treatment group.
    End point values
    		 Immunogenicity Population Arm 1a: HB-101: Preemptive Immunogenicity Population Arm 1b: Placebo: Preemptive Immunogenicity Population Arm 2a: HB-101: Prophylactic Immunogenicity Population Arm 2b: Placebo: Prophylactic Immunogenicity Population Group 3: HB-101: CMV (+) preemptive Immunogenicity Population Group 3 HB-101: CMV (+) Prophylactic
    Number of subjects analysed
    6
    2
    15
    7
    1
    4
    Units: log10 virus neutralising unit(s)
        geometric mean (confidence interval 95%)
    6.1 (3.0 to 12.3)
    4 (4 to 4)
    6.6 (4.0 to 10.9)
    5.8 (2.4 to 14.0)
    314.0 (314.0 to 314.0)
    375.0 (228.1 to 615.1)
    No statistical analyses for this end point

    Primary: Reactogenicity: Local - Injection site reactions

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    End point title
    		 Reactogenicity: Local - Injection site reactions [7]
    End point description
    Incidence and severity of localized injection site reactions were summarized by symptom type and by injection site and symptom type for the Safety Population. Group 1 and 2: The majority of local injection site reactions did not receive a Grade (mild, moderate, or severe); however, of those that did receive a Grade, the majority were mild. There were no severe or life threatening injection site reactions reported. The majority of local injection site reactions between patients who received HB-101 were comparable to patients who received placebo. There were more patients that reported mild tenderness in the HB-101 treatment group versus the placebo treatment group (5 [11.1%] patients versus 1 [4.8%] patient, respectively). Group 3: The majority of local injection site reactions did not receive a Grade (mild, moderate, or severe); however, of those that did receive a Grade, the majority were mild. There were no severe or life threatening injection site reactions reported.
    End point type
    Primary
    End point timeframe
    Potential signs/symptoms of reactogenicity were assessed after each study drug administration. Fifteen (15) months.
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: For assessing the safety and reactogenicity of HB-101, the incidence and severity of localized or generalized injection site reactions were summarized by descriptive statistics, by symptom type and by injection site and symptom type for the Safety Population.
    End point values
    		 Safety Population Arm 1a: HB-101: Preemptive Safety Population Arm 2a: HB-101: Prophylactic Safety Population Arm 1b: Placebo: Preemptive Safety Population Arm 2b: Placebo: Prophylactic Safety Population Group 3: HB-101: CMV (+): Preemptive Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Number of subjects analysed
    11
    34
    4
    17
    4
    10
    Units: patients
    2
    9
    0
    4
    4
    5
    No statistical analyses for this end point

    Primary: Reactogenicity: General- Injection site reactions

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    End point title
    		 Reactogenicity: General- Injection site reactions [8]
    End point description
    The incidence and severity of generalized injection site reactions were summarized by symptom type and by injection site and symptom type for the Safety Population. Group 1 and 2: The majority of systemic (general) injection site reactions did not receive a Grade (mild, moderate, or severe); however, of those that did receive a Grade, the majority were mild. There were no severe or life threatening injection site reactions. Overall, there were more patients that reported systemic (general) injection site reactions to study drug in the HB-101 treatment group versus the placebo treatment group. Group 3: The majority of systemic (general) injection site reactions did not receive a Grade (mild, moderate, or severe); however, of those that did receive a Grade, the majority were mild. There were no severe or life threatening injection site reactions.
    End point type
    Primary
    End point timeframe
    Potential signs/symptoms of reactogenicity were assessed after each study drug administration. Fifteen (15) months.
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: For assessing the safety and reactogenicity of HB-101, the incidence and severity of localized or generalized injection site reactions were summarized by descriptive statistics, by symptom type and by injection site and symptom type for the Safety Population.
    End point values
    		 Safety Population Arm 1a: HB-101: Preemptive Safety Population Arm 2a: HB-101: Prophylactic Safety Population Arm 1b: Placebo: Preemptive Safety Population Arm 2b: Placebo: Prophylactic Safety Population Group 3: HB-101: CMV (+): Preemptive Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Number of subjects analysed
    11
    34
    4
    17
    4
    10
    Units: patients
    2
    9
    0
    4
    4
    5
    No statistical analyses for this end point

    Primary: CMV neutralizing antibody titers (NTAs) at day of Transplant for 3 doses

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    End point title
    		 CMV neutralizing antibody titers (NTAs) at day of Transplant for 3 doses [9]
    End point description
    GMT=geometric mean titer (defined as the antilog10 of the mean of log10 values). The CMV neut parameter underwent all tests and summaries of the other parameters with the addition of a 95% confidence interval of the geometric mean titer. Overall, 12 patients treated with HB-101 had positive CMV titers on the day of transplant: 2 (33.3%) patients who received 2 doses of HB-101 and preemptive care; 1 (50.0%) patient who received 3 doses of HB-101 and preemptive care; 4 (26.7%) patients who received 2 doses of HB-101 and prophylactic treatment; and 5 (100.0%) patients who received 3 doses of HB-101 and prophylactic treatment. Compared to placebo, more patients treated with HB-101 had positive CMV titers on the day of transplant. Patients who received 3 doses of HB-101 and prophylactic treatment had statistically significant higher CMV titers compared to placebo (p=0.0022) on the day of transplant.
    End point type
    Primary
    End point timeframe
    Day of transplant. Three (3) months.
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: CMV neutralizing antibody titers (NTAs) at day of transplant for 3 doses were summarized by descriptive statistics for each treatment group.
    End point values
    		 Immunogenicity Population Arm 1a: HB-101: Preemptive Immunogenicity Population Arm 1b: Placebo: Preemptive Immunogenicity Population Arm 2a: HB-101: Prophylactic Immunogenicity Population Arm 2b: Placebo: Prophylactic Immunogenicity Population Group 3: HB-101: CMV (+) preemptive Immunogenicity Population Group 3 HB-101: CMV (+) Prophylactic
    Number of subjects analysed
    2
    2
    5
    6
    2
    1
    Units: log10 virus neutralising unit(s)
        geometric mean (confidence interval 95%)
    11.7 (0.0 to 999)
    4.0 (4.0 to 4.0)
    26.9 (13.7 to 52.8)
    4.0 (4.0 to 4.0)
    334.7 (0.0 to 999)
    464.0 (464.0 to 464.0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) were recorded from the time of the first injection of study drug up through 30 days after the last injection. Only AEs considered by the Investigator to be related to study drug were recorded from 31 days to End of Study Visit.
    Adverse event reporting additional description
    Listings are presented specifically for non serious treatment-emergent AEs (TEAEs) and serious TEAEs occurred pre- and post-transplant in the Safety Population. The Safety Population includes all patients in the Intent-to-Treat (ITT) Population who received any study drug and were analyzed by their actual treatment group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Safety Population Arm 1a: HB-101: Preemptive
    Reporting group description
    		 The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 1a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive HB-101 before transplant, and monitoring after transplant.

    Reporting group title
    Safety Population Arm 1b: Placebo: Preemptive
    Reporting group description
    		 The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 1b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor randomized to receive placebo before transplant, and monitoring after transplant.

    Reporting group title
    Safety Population Arm 2a: HB-101: Prophylactic
    Reporting group description
    		 The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 2a: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive HB-101 before transplant, and anti-viral prophylaxis and monitoring after transplant.

    Reporting group title
    Safety Population Arm 2b: Placebo: Prophylactic
    Reporting group description
    		 The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Arm 2b: CMV seronegative (-) patients awaiting kidney transplant from a CMV seropositive (+) living donor to receive placebo before transplant, and anti-viral prophylaxis and monitoring after transplant.

    Reporting group title
    Safety Population Group 3: HB-101: CMV (+) patient: preemptive
    Reporting group description
    		 The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant CMV management followed preemptive care as defined at study enrollment by the Investigator and institutional standards.

    Reporting group title
    Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Reporting group description
    		 The Safety Population included all patients in the Intent-to-Treat (ITT) Population who received any study drug. Adult CMV seropositive (+) patients awaiting kidney transplant from a CMV seropositive (+) or CMV seronegative (-) living donor were enrolled into Group 3. Post-transplant patients received anti-viral prophylaxis following institutional standards.

    Serious adverse events
    		 Safety Population Arm 1a: HB-101: Preemptive Safety Population Arm 1b: Placebo: Preemptive Safety Population Arm 2a: HB-101: Prophylactic Safety Population Arm 2b: Placebo: Prophylactic Safety Population Group 3: HB-101: CMV (+) patient: preemptive Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 11 (45.45%)
    2 / 4 (50.00%)
    14 / 34 (41.18%)
    5 / 17 (29.41%)
    2 / 4 (50.00%)
    2 / 10 (20.00%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    1
    0
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Kidney transplant rejection
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 4 (0.00%)
    2 / 34 (5.88%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transplant rejection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    2 / 34 (5.88%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    2 / 10 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatine increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HLA marker study positive
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    3 / 34 (8.82%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    3 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Bicuspid aortic valve
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary ostial stenosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal artery thrombosis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal tubular injury
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperparathyroidism tertiary
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Neuropathic arthropathy
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    corona virus infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus viraemia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    1 / 34 (2.94%)
    3 / 17 (17.65%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterobacter infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis viral
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Population Arm 1a: HB-101: Preemptive Safety Population Arm 1b: Placebo: Preemptive Safety Population Arm 2a: HB-101: Prophylactic Safety Population Arm 2b: Placebo: Prophylactic Safety Population Group 3: HB-101: CMV (+) patient: preemptive Safety Population Group 3: HB-101: CMV (+): Prophylactic
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 11 (54.55%)
    3 / 4 (75.00%)
    23 / 34 (67.65%)
    12 / 17 (70.59%)
    3 / 4 (75.00%)
    6 / 10 (60.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 4 (50.00%)
    2 / 34 (5.88%)
    3 / 17 (17.65%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    2
    2
    3
    0
    1
    Hypotension
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pallor
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Surgical and medical procedures
    Skin cyst excision
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    4 / 34 (11.76%)
    1 / 17 (5.88%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    4
    1
    1
    0
    Influenza like illness
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 4 (0.00%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    2 / 34 (5.88%)
    1 / 17 (5.88%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    3
    1
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Asthenia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hyperthermia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oedema
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Swelling
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Vaccination site pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vessel puncture site pruritus
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Kidney transplant rejection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Asthma
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Rales
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Investigations
    Blood creatine increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Cytomegalovirus test positive
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    BK polyomavirus test
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood immunoglobulin A increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Breath sounds abnormal
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    HLA marker study positive
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Liver function test increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Urine output decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Crossmatch incompatible
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Donor specific antibody present
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    4 / 34 (11.76%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    4
    1
    0
    0
    Complications of transplanted kidney
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Delayed graft function
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Incision site pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Post procedural discharge
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Post procedural haematoma
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Transplantation complication
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vascular graft stenosis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    1 / 34 (2.94%)
    2 / 17 (11.76%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    1
    2
    0
    0
    Tremor
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    2 / 17 (11.76%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    0
    Dysaesthesia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    2 / 4 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    3
    0
    Paraesthesia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 4 (25.00%)
    2 / 34 (5.88%)
    3 / 17 (17.65%)
    3 / 4 (75.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    2
    3
    3
    0
    Leukopenia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nephrogenic anaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pancytopenia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Meniere's disease
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vertigo
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Eye disorders
    Scleritis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Xanthopsia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 4 (50.00%)
    1 / 34 (2.94%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    4
    2
    1
    1
    0
    0
    Nausea
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 4 (25.00%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    2 / 10 (20.00%)
         occurrences all number
    2
    1
    2
    0
    1
    3
    Diarrhoea
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    3 / 34 (8.82%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    0
    3
    0
    0
    2
    Vomiting
         subjects affected / exposed
    3 / 11 (27.27%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    3
    0
    0
    1
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Dysphagia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Hepatobiliary disorders
    Hepatocellular injury
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Cholestasis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    pruritus generalised
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Purpura senile
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Rash macular
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Acute kidney injury
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Nocturia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Oliguria
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Renal pain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Renal impairment
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Urethral spasm
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Endocrine disorders
    Hyperparathyroidism secondary
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    1 / 17 (5.88%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    1
    1
    0
    Chronic kidney disease-mineral and bone disorder
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    2 / 17 (11.76%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    2 / 4 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    Pain in extremity
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    Infections and infestations
    Cytomegalovirus viraemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    2 / 34 (5.88%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    2
    2
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    2 / 34 (5.88%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    2
    2
    0
    0
    Cytomegalovirus infection
         subjects affected / exposed
    3 / 11 (27.27%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    8
    0
    0
    0
    1
    0
    Bacteraemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Coronavirus infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Epididymitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Haematoma infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pseudomonas infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hypophosphataemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    2 / 34 (5.88%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    2
    1
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    2
    0
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    3 / 34 (8.82%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    4
    0
    0
    0
    Gout
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 4 (25.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    2 / 34 (5.88%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    2 / 17 (11.76%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    1 / 17 (5.88%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    1
    1
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    1 / 34 (2.94%)
    0 / 17 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    1 / 17 (5.88%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Calcium deficiency
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    2 / 4 (50.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Folate deficiency
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 4 (0.00%)
    0 / 34 (0.00%)
    0 / 17 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Jun 2019
    Global Protocol Amendment 1 (Version 4.0) dated 26 June 2019 was developed to respond to regulatory feedback and investigational site feedback. The key changes are summarized below: - The language describing the study design was modified throughout the study Protocol to provide further clarity on how much time should have been scheduled between study drug injections and when additional study drug injections should have been administered; - The maximum allowed number of patients receiving additional study drug injections was capped at 10 patients (less than 10% of planned sample size); - A window of ±2 days was added to the minimum of 7 days that was planned between the last dose of study drug and transplantation; - Language was also added throughout the study Protocol to specify procedures for patients who received a kidney from a deceased donor or patients who were paired with a CMV seronegative (-) donor; - New sections were added to define the end of the study and the early study termination; - The definition of abstinence and a clarification note were added to Inclusion Criterion 8 describing contraception use; - Inclusion Criterion 7 was deleted due to redundancy with Inclusion Criterion 9; - Language was added to describe how to handle a patient who had a false positive pregnancy test; - Exclusion Criterion 17 was added to exclude patients who received Cytogam® in their post transplant prophylaxis regimen; - A new section was added to describe the procedures for discontinuation of study drug and language was added to the withdrawal criteria to describe procedures for withdrawal of consent and discontinuation of study drug; - The study assessments were updated to allow for the study visit occurring 7 days after study drug administration to be conducted via phone call, in the event that the patient cannot return to the site; - A new section was added to clarify the procedures for the CMR PCR testing (locally versus centrally).
    07 Nov 2019
    Global Protocol Amendment 2 (Version 5.0) dated 07 November 2019 was developed to incorporate the following: - Addition of an open-label Group 3 to the study design that included patients who were CMV seropositive (+) awaiting a kidney transplant from a CMV seropositive (+) or seronegative (-) living donor; -- Patients enrolled in Group 3 received open-label HB-101 and were followed with a post transplant CMV management strategy per institutional standard (either preemptive or prophylactic care);- -- Safety and reactogenicity, immunogenicity, and efficacy of HB-101 were assessed in Group 3 patients. Study drug dosing and all assessments for Group 3 were the same as for Groups 1 and 2 per existing schedules for dosing and procedures; and -- The safety, immunogenicity, and efficacy data collected from this patient population were to provide critical information for the registration trial based on the broad population of patients who are at intermediate and high risk of developing clinically significant CMV infections post-transplantation. - Inclusion of a urine sample in addition to serum sample for pregnancy tests to be acceptable.
    09 Dec 2020
    Global Protocol Amendment 3 (Version 6.0) dated 09 December 2020 was developed to incorporate the following: - HLA sensitization was added as a risk related to administration of vaccines based on the Sponsor’s understanding of the risk of HLA sensitization posed by the investigational CMV vaccine HB-101 and to offer a recommendation to mitigate this risk. Additionally, patients’ HLA genotypes were considered during Screening. -- To minimize the risk of HLA sensitizations in patients enrolled, the Protocol was amended to enroll only those patients who had no risk or low risk of sensitization owing to tolerance against the r relevant HLA epitopes. - Assessment of additional immunogenicity parameters of HB-101 by CMV ICS pp65 and CMV ICS gB assays were moved from secondary to exploratory endpoints. - Assessment of LCMV neutralizing antibody and LCMV NP-specific ELISPOT were moved from secondary to exploratory endpoints.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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