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    Summary
    EudraCT Number:2017-005047-32
    Sponsor's Protocol Code Number:H-100-002
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-26
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2017-005047-32
    A.3Full title of the trial
    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+)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test a new vaccine, in avoiding cytomegalovirus (CMV) infection after transplant, if you have never encountered the virus and your donor may harbor it.
    A.4.1Sponsor's protocol code numberH-100-002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHookipa Biotech GmbH
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHookipa Biotech GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHookipa Biotech GmbH
    B.5.2Functional name of contact pointGeneral Contact
    B.5.3 Address:
    B.5.3.1Street AddressHelmut-Qualtinger-Gasse 2
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1030
    B.5.3.4CountryAustria
    B.5.4Telephone number+4318906360
    B.5.6E-mailoffice@hookipapharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code HB-101
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeHK1-HPP65
    D.3.9.3Other descriptive namerLCMV vector (HK1) encoding human CMV phosphoprotein 65 kD (Hpp65)
    D.3.9.4EV Substance CodeSUB182581
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number87600000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeHK1-HGB
    D.3.9.3Other descriptive namerLCMV vector (HK1) encoding human CMV Glycoprotein B (HgB)
    D.3.9.4EV Substance CodeSUB182582
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62500000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of clinically significant cytomegalovirus (CMV) infection
    E.1.1.1Medical condition in easily understood language
    CMV can cause serious illness in people with weakened immune system (like cancer treatment, HIV, organ transplant) and can cause birth defects in the unborn child.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10072247
    E.1.2Term Cytomegalovirus immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the safety and reactogenicity of HB-101.

    2. To assess the immunogenicity of HB-101.
    E.2.2Secondary objectives of the trial
    1.To assess the efficacy of the administration of at least 2 doses of HB101 compared to that of placebo in mitigating CMV DNAemia/viremia CMV
    seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and followed by CMV preemptive therapy post-transplant.
    2.To assess the efficacy of the administration of at least 2 doses of HB101 compared to that of placebo in decreasing the use of anti-virals at treatment
    dose for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and to be treated prophylactically for CMV post transplant.
    3.To assess the efficacy of the administration of at least 2 doses of HB101 in CMV seropositive (+) recipients awaiting kidney transplant and followed
    by CMV post transplant preemptive management or prophylactic anti-viral therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients 18 years of age or older.
    2. Patients willing and able to give written informed consent for participation in the study.
    3. Patients must be eligible to undergo kidney transplantation from a living donor as per institutional standards.
    4. For Group 1 and 2, patients must be CMV immunoglobulin G (IgG) seronegative (-) and will be receiving kidney for transplantation from donors who are CMV IgG seropositive (+). (If CMV IgG serology is indeterminate, repeat testing is recommended. If the serology for the donor is indeterminate upon repeat testing, it should be considered positive; if the serology for the recipient is indeterminate upon repeat testing, it should be considered negative).
    5. For Group 3, patients must be CMV IgG seropositive (+) and will be receiving a kidney for transplantation from donors who are CMV IgG seropositive (+) or CMV IgG seronegative (- ). Group 3 patients must have documentation of a planned transplant that is scheduled to occur between 2 and 4 months after the first study drug injection.
    6. Post-transplant CMV management will follow either preemptive treatment strategy (Group 1) or prophylactic anti-viral medication(s) (e.g., alganciclovir) per institutional standard of practice (Group2).
    7. Female patients of childbearing potential can participate in the study if they agree to use highly effective contraception. This applies from the time period between signing of the informed consent form and up to 12 months after the last study drug (HB-101 or placebo) injection or up to completion of the study, whichever is longer.
    Highly effective contraception methods include:
    • Total abstinence.
    • Male or female sterilization.
    • Combination of any 2 of the following categories (Categories 1+2, 1+3, or 2+3):
    o Category 1: Use of oral, injected, or implanted hormonal methods of contraception.
    o Category 2: Placement of an intrauterine device or intrauterine system.
    o Category 3: Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
    8. Female patients must have a negative serum human chorionic gonadotropin pregnancy test prior to each dose of study drug (HB-101 or placebo) unless the pregnancy test is deemed a false positive and clinical evidence is negative for pregnancy after discussion between the sponsor and investigator on a case-by-case basis; or be surgically or biologically sterile or post menopausal.
    Post-menopausal females are defined as:
    • Age >50 years with amenorrhea for at least 12 months.
    • Age <=50 years with 6 months of spontaneous amenorrhea and follicle-stimulating hormone level within post-menopausal range (>40 mIU/mL).
    • Permanently sterilized women (hysterectomy or bilateral oophorectomy).
    9. Male patients with sexual partners of childbearing potential can participate in the study if they agree to use barrier contraception from the time period between signing of the informed consent form and through 3 months after the last dose of study drug.
    10. Male patients must agree to refrain from sperm donation from the time period between signing of the informed consent form and through 3 months after the last dose of study drug.
    11. Patients who would comply with the requirements of this protocol (e.g., return for follow up visits), as judged by the investigator.
    E.4Principal exclusion criteria
    1. Patients who are highly sensitized or who are likely to undergo desensitization at time of transplant (e.g., donor-specific antibody titers at the local laboratory >2000). Only patients with no risk or low risk of sensitization defined in the study protocol should be enrolled, owing to tolerance against the relevant HLA epitopes.
    2. Patients planning to undergo multi-organ transplantation.
    3. Patients participating in another interventional clinical study.
    4. Previous vaccination with an investigational CMV vaccine.
    5. Patients with known diagnosis of human immunodeficiency virus.
    6. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study.
    7. Any Screening safety laboratory value of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 X upper limit of normal (ULN), total bilirubin >2 X ULN, absolute neutrophil count <500 cells/µL, or lymphocyte count <200 cells/µL.
    8. Any confirmed or suspected immunodeficiency disorder (based on medical history and physical examination) that could interfere with the immune response or that presents a risk for the patient to receive a vaccine candidate in development.
    9. Treatment with any chronic immunosuppressive medication or other immuno modifying drugs within 6 months prior to study entry (unless agreed otherwise between the sponsor and investigator on a case-by-case basis). However, inhaled and topical steroids and low-dose oral corticosteroids (≤10 milligrams a day of prednisone or equivalent) are allowed.
    10. For Groups 1 and 2 only, patients with prior history of CMV disease or CMV infection requiring anti-viral therapy.
    11. For Group 3 only, patients with active CMV infection requiring antiviral therapy within 30 days prior to the first injection of study drug.
    12. Patients with a history of severe allergic reactions and/or anaphylaxis that could interfere with the immune response (including an allergy or hypersensitivity to any ingredient found in the study drug [HB-101 or placebo]) or that presents a risk for the patient to receive a vaccine candidate in development.
    13. Patients with a severe coagulation abnormality that would preclude intramuscular injection.
    14. Patients with a rash, dermatological condition, or tattoo in the area of the injection site(s) that could interfere with administration site reaction rating. (Note: The injection site(s) can be the non-dominant arm [most preferred injection site], dominant arm, or either thigh [least preferred injection site], as judged by the investigator).
    15. History or current evidence of medical disorders or conditions that could prevent the successful completion of the study, as judged by the investigator.
    16. It is anticipated that the patient will be unavailable to complete study follow-up.
    17. Fever (>= 38°C) occurs within 7 days prior to first dose (unless agreed otherwise between the sponsor and investigator on a case-by-case basis).
    18.For patients receiving the post-transplant CMV prophylactic therapy management group only, patients who will be receiving Cytogam® in their post-transplant CMV prophylaxis regimen.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and reactogenicity of HB-101 will be assessed by treatment group (for Groups 1 and 2 and open-label HB-101 for Group 3) and by number
    of vaccinations:
    1.Incidence and severity of AEs, SAEs, and changes in laboratory values
    2.Incidence and severity of localized or generalized injection site
    reactions
    The immunogenicity of HB-101 will be assessed using descriptive central statistics presented by treatment group (for Groups 1 and 2 and open-label
    HB-101 for Group 3) and by post-transplant CMV management strategy (prevention or preemption) for the following immunogenicity parameters:
    3.CMV neut
    4.CMV ELISPOT pp65
    5.CMV ELISPOT gB
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.From the time of the first injection of study drug (HB-101 or placebo) up through 30 days after the last injection of study drug.
    From 31 days after the last injection of study drug up through the End of Study Visit.
    After transplant up to the End of the Study Visit.
    Through the study
    Until repeat test return to normal, stabilize, or are no longer clinically significant.

    2.Prior to study drug administration on study drug dosing days
    On treatment days for at least 60 minutes after study drug administration

    3., 4. and 5.Each day of dosing, the day of the transplant and 3,6 and 9 months after the transplant, at the end of study visit.
    E.5.2Secondary end point(s)
    1.Incidence and time to clinically significant CMV infection, CMV disease, and CMV syndrome
    2.Incidence and time to CMV viremia requiring anti viral therapy
    3.Incidence and duration (in days) of anti-CMV therapy courses (at therapeutic doses) required
    4.Incidence and time to quantifiable CMV DNAemia, peak CMV DNAemia level, and duration of CMV DNAemia above the limit of quantitation
    5.Incidence and time to graft failure and organ rejection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1., 2., 3., 4. and 5. Through 12 months after transplant
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Austria
    Belgium
    Denmark
    France
    Germany
    Netherlands
    Norway
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Visit Last Subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will follow their standard of care treatment
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-22
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