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    Clinical Trial Results:
    A Phase 2 Randomized, Multi-Center Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine Candidate in HIV-Infected Adults and Adolescents

    Summary
    EudraCT number
    		 2016-004853-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 May 2026
    First version publication date
    03 May 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CT1401-B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03031912
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Canadian Immunization Research Network (CIRN) Project Management Office
    Sponsor organisation address
    5850/5980 University Avenue, Halifax, Canada, B3K 6R8
    Public contact
    Canadian Immunization Research Network, Canadian Immunization Research Network, 1 902470-8141, ccfv@iwk.nshealth.ca
    Scientific contact
    Canadian Immunization Research Network, Canadian Immunization Research Network, 1 902470-8141, ccfv@iwk.nshealth.ca
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001786-PIP01-15
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Mar 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the safety and tolerability of V920 in HIV-infected adults and adolescents. Evaluate the immunogenicity of V920 via ZEBOV- specific antibody responses induced by V920 in HIV-infected adults and adolescents.
    Protection of trial subjects
    This study was conducted in accordance with Good Clinical Practice (GCP) and applicable regulatory requirements. Safety monitoring occurred throughout the study (SAEs, AEs) up to 1-year post-vaccination.
    Background therapy
    		 All participants were on antiretroviral therapy with an undetectable viral load (< 40 c/ml).
    Evidence for comparator
    		 A placebo was used as the comparator as there was no other standard of care Ebola vaccine available at the time of the study start.
    Actual start date of recruitment
    01 Aug 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 26
    Country: Number of subjects enrolled
    Senegal: 73
    Country: Number of subjects enrolled
    Burkina Faso: 152
    Worldwide total number of subjects
    251
    EEA total number of subjects
    0
    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)
    65
    Adults (18-64 years)
    184
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 First participant was enrolled in November 2017, and the last participant was enrolled in March 2022.

    Pre-assignment
    Screening details
    		 A total of 641 potential participants were screened, 251 were randomized and 250 received study vaccine or placebo.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: V920
    Arm description
    		 Adults with screening CD4 cells/mm3 ≥ 500 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 Ebola Virus Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    rVSVΔG-ZEBOV-GP vaccine (V920) will be administered as an IM injection. V920 should be removed from the freezer and thawed at room temperature (not 2-8°C) for approximately 10-15 minutes. The thawed vial should then be gently inverted several times prior to withdrawal with the syringe. An unblinded pharmacist (or other designated unblinded person) at the site will be required to prepare the study vaccine/placebo in order to maintain the blinding. Both study vaccine and placebo are clear, and indistinguishable from one another once in the syringe. Once the syringe is prepared, the blinded personnel will administer the study vaccine/placebo to the subject. All subjects will receive, on Day 0 either the V920 (rVSVΔG-ZEBOV-GP) vaccine at a dose of ≥2x107 PFU in 1mL IM, or normal saline (0.9%) placebo control in 1mL volume.

    Arm title
    		 Cohort 1: Placebo
    Arm description
    		 Adults with screening CD4 cells/mm3 ≥500 randomly assigned to receive placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline (0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    Placebo is administered as an IM injection. An unblinded pharmacist (or other designated unblinded person) at the site will be required to prepare the study placebo in order to maintain the blinding. Both study vaccine and placebo are clear, and indistinguishable from one another once in the syringe. Once the syringe is prepared, the blinded personnel will administer the study vaccine/placebo to the subject. Placebo recipients receive normal saline (0.9%) placebo control in 1mL volume.

    Arm title
    		 Cohort 2: V920
    Arm description
    		 Adults with screening CD4 cells/mm3 >350 and <500 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 Ebola Virus Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    rVSVΔG-ZEBOV-GP vaccine (V920) will be administered as an IM injection. V920 should be removed from the freezer and thawed at room temperature (not 2-8°C) for approximately 10-15 minutes. The thawed vial should then be gently inverted several times prior to withdrawal with the syringe. An unblinded pharmacist (or other designated unblinded person) at the site will be required to prepare the study vaccine/placebo in order to maintain the blinding. Both study vaccine and placebo are clear, and indistinguishable from one another once in the syringe. Once the syringe is prepared, the blinded personnel will administer the study vaccine/placebo to the subject. All subjects will receive, on Day 0 either the V920 (rVSVΔG-ZEBOV-GP) vaccine at a dose of ≥2x107 PFU in 1mL IM, or normal saline (0.9%) placebo control in 1mL volume.

    Arm title
    		 Cohort 2: Placebo
    Arm description
    		 Adults with screening CD4 cells/mm3 >350 and <500 randomly assigned to receive placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline (0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    Placebo is administered as an IM injection. An unblinded pharmacist (or other designated unblinded person) at the site will be required to prepare the study placebo in order to maintain the blinding. Both study vaccine and placebo are clear, and indistinguishable from one another once in the syringe. Once the syringe is prepared, the blinded personnel will administer the study vaccine/placebo to the subject. Placebo recipients receive normal saline (0.9%) placebo control in 1mL volume.

    Arm title
    		 Cohort 3: V920
    Arm description
    		 Adults with screening CD4 cells/mm3 ≥200 and ≤350 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 Ebola Virus Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    rVSVΔG-ZEBOV-GP vaccine (V920) will be administered as an IM injection. V920 should be removed from the freezer and thawed at room temperature (not 2-8°C) for approximately 10-15 minutes. The thawed vial should then be gently inverted several times prior to withdrawal with the syringe. An unblinded pharmacist (or other designated unblinded person) at the site will be required to prepare the study vaccine/placebo in order to maintain the blinding. Both study vaccine and placebo are clear, and indistinguishable from one another once in the syringe. Once the syringe is prepared, the blinded personnel will administer the study vaccine/placebo to the subject. All subjects will receive, on Day 0 either the V920 (rVSVΔG-ZEBOV-GP) vaccine at a dose of ≥2x107 PFU in 1mL IM, or normal saline (0.9%) placebo control in 1mL volume.

    Arm title
    		 Cohort 3: Placebo
    Arm description
    		 Adults with screening CD4 cells/mm3 ≥200 and ≤350 randomly assigned to receive placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline (0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    Placebo is administered as an IM injection. An unblinded pharmacist (or other designated unblinded person) at the site will be required to prepare the study placebo in order to maintain the blinding. Both study vaccine and placebo are clear, and indistinguishable from one another once in the syringe. Once the syringe is prepared, the blinded personnel will administer the study vaccine/placebo to the subject. Placebo recipients receive normal saline (0.9%) placebo control in 1mL volume.

    Arm title
    		 Cohort 4: V920
    Arm description
    		 Adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 Ebola Virus Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    rVSVΔG-ZEBOV-GP vaccine (V920) will be administered as an IM injection. V920 should be removed from the freezer and thawed at room temperature (not 2-8°C) for approximately 10-15 minutes. The thawed vial should then be gently inverted several times prior to withdrawal with the syringe. An unblinded pharmacist (or other designated unblinded person) at the site will be required to prepare the study vaccine/placebo in order to maintain the blinding. Both study vaccine and placebo are clear, and indistinguishable from one another once in the syringe. Once the syringe is prepared, the blinded personnel will administer the study vaccine/placebo to the subject. All subjects will receive, on Day 0 either the V920 (rVSVΔG-ZEBOV-GP) vaccine at a dose of ≥2x107 PFU in 1mL IM, or normal saline (0.9%) placebo control in 1mL volume.

    Arm title
    		 Cohort 4: Placebo
    Arm description
    		 Adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline (0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    Placebo is administered as an IM injection. An unblinded pharmacist (or other designated unblinded person) at the site will be required to prepare the study placebo in order to maintain the blinding. Both study vaccine and placebo are clear, and indistinguishable from one another once in the syringe. Once the syringe is prepared, the blinded personnel will administer the study vaccine/placebo to the subject. Placebo recipients receive normal saline (0.9%) placebo control in 1mL volume.

    Arm title
    		 Cohort 5: V920
    Arm description
    		 Adults and adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine. This cohort received 2 doses 56 days apart.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V920 Ebola Virus Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    rVSVΔG-ZEBOV-GP vaccine (V920) will be administered as an IM injection. V920 should be removed from the freezer and thawed at room temperature (not 2-8°C) for approximately 10-15 minutes. The thawed vial should then be gently inverted several times prior to withdrawal with the syringe. An unblinded pharmacist (or other designated unblinded person) at the site will be required to prepare the study vaccine/placebo in order to maintain the blinding. Both study vaccine and placebo are clear, and indistinguishable from one another once in the syringe. Once the syringe is prepared, the blinded personnel will administer the study vaccine/placebo to the subject. All subjects will receive, on Day 0 either the V920 (rVSVΔG-ZEBOV-GP) vaccine at a dose of ≥2x107 PFU in 1mL IM, or normal saline (0.9%) placebo control in 1mL volume.

    Arm title
    		 Cohort 5: Placebo
    Arm description
    		 Adults and adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive placebo. This cohort received 2 doses 56 days apart.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal Saline (0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    Placebo is administered as an IM injection. An unblinded pharmacist (or other designated unblinded person) at the site will be required to prepare the study placebo in order to maintain the blinding. Both study vaccine and placebo are clear, and indistinguishable from one another once in the syringe. Once the syringe is prepared, the blinded personnel will administer the study vaccine/placebo to the subject. Placebo recipients receive normal saline (0.9%) placebo control in 1mL volume.

    Number of subjects in period 1
    		Cohort 1: V920 Cohort 1: Placebo Cohort 2: V920 Cohort 2: Placebo Cohort 3: V920 Cohort 3: Placebo Cohort 4: V920 Cohort 4: Placebo Cohort 5: V920 Cohort 5: Placebo
    Started
    41
    10
    40
    10
    41
    9
    40
    10
    40
    10
    Completed
    41
    10
    40
    10
    41
    9
    40
    10
    40
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: V920
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥ 500 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 1: Placebo
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥500 randomly assigned to receive placebo.

    Reporting group title
    Cohort 2: V920
    Reporting group description
    		 Adults with screening CD4 cells/mm3 >350 and <500 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 2: Placebo
    Reporting group description
    		 Adults with screening CD4 cells/mm3 >350 and <500 randomly assigned to receive placebo.

    Reporting group title
    Cohort 3: V920
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥200 and ≤350 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 3: Placebo
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥200 and ≤350 randomly assigned to receive placebo.

    Reporting group title
    Cohort 4: V920
    Reporting group description
    		 Adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 4: Placebo
    Reporting group description
    		 Adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive placebo.

    Reporting group title
    Cohort 5: V920
    Reporting group description
    		 Adults and adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine. This cohort received 2 doses 56 days apart.

    Reporting group title
    Cohort 5: Placebo
    Reporting group description
    		 Adults and adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive placebo. This cohort received 2 doses 56 days apart.

    Reporting group values
    		 Cohort 1: V920 Cohort 1: Placebo Cohort 2: V920 Cohort 2: Placebo Cohort 3: V920 Cohort 3: Placebo Cohort 4: V920 Cohort 4: Placebo Cohort 5: V920 Cohort 5: Placebo Total
    Number of subjects
    		 41 10 40 10 41 9 40 10 40 10 251
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 40 10 12 3 65
        Adults (18-65 years)
    		 40 10 39 10 41 9 0 0 28 7 184
        Adults (>65 years)
    		 1 0 1 0 0 0 0 0 0 0 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.1 ( 8.0 ) 48.9 ( 8.6 ) 48.1 ( 8.3 ) 49.9 ( 7.0 ) 46.6 ( 11.1 ) 44.1 ( 8.8 ) 15.0 ( 1.5 ) 14.5 ( 1.4 ) 33.1 ( 15.2 ) 33.8 ( 19 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 6 24 7 18 6 20 7 21 4 130
        Male
    		 24 4 16 3 23 3 20 3 19 6 121
    Race/Ethnicity
    Units: Subjects
        Black or African American
    		 21 5 39 10 41 9 40 10 40 10 225
        Multiple - Asian, White
    		 0 1 0 0 0 0 0 0 0 0 1
        White
    		 20 4 1 0 0 0 0 0 0 0 25

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: V920
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥ 500 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 1: Placebo
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥500 randomly assigned to receive placebo.

    Reporting group title
    Cohort 2: V920
    Reporting group description
    		 Adults with screening CD4 cells/mm3 >350 and <500 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 2: Placebo
    Reporting group description
    		 Adults with screening CD4 cells/mm3 >350 and <500 randomly assigned to receive placebo.

    Reporting group title
    Cohort 3: V920
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥200 and ≤350 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 3: Placebo
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥200 and ≤350 randomly assigned to receive placebo.

    Reporting group title
    Cohort 4: V920
    Reporting group description
    		 Adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 4: Placebo
    Reporting group description
    		 Adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive placebo.

    Reporting group title
    Cohort 5: V920
    Reporting group description
    		 Adults and adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine. This cohort received 2 doses 56 days apart.

    Reporting group title
    Cohort 5: Placebo
    Reporting group description
    		 Adults and adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive placebo. This cohort received 2 doses 56 days apart.

    Primary: Number of participants with solicited adverse events following V920 vaccination

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    End point title
    		 Number of participants with solicited adverse events following V920 vaccination [1]
    End point description
    The number of participants with general solicited local (at the injection site) and systemic adverse events following vaccination will be summarized. Local AES are pain at injection site, redness/erythema at injection site, swelling at injection site Systemic AEs are arthralgia, joint swelling, feeling hot, sweats, chills, fatigue, diarrhea, nausea/vomiting, headache, abdominal pain, myalgia, rash, blisters, pyrexia and hyperhidrosis.
    End point type
    Primary
    End point timeframe
    From vaccine administration up to day 14 following vaccination
    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: The analyses for this endpoint were descriptive only, based on counts and percentages. No statistical testing was performed.
    End point values
    		 Cohort 1: V920 Cohort 1: Placebo Cohort 2: V920 Cohort 2: Placebo Cohort 3: V920 Cohort 3: Placebo Cohort 4: V920 Cohort 4: Placebo Cohort 5: V920 Cohort 5: Placebo
    Number of subjects analysed
    40
    10
    40
    10
    41
    9
    40
    10
    40
    10
    Units: Participants
        Local - injection site erythema
    5
    1
    2
    1
    2
    0
    0
    0
    0
    0
        Local - Injection site pain
    22
    3
    20
    3
    24
    1
    34
    3
    30
    2
        Local - Injection site swelling
    4
    0
    0
    1
    2
    0
    4
    1
    1
    1
        Systemic - Abdominal pain
    4
    0
    5
    1
    4
    1
    4
    1
    8
    1
        Systemic - Arthralgia
    14
    0
    16
    2
    7
    1
    3
    0
    10
    1
        Systemic - Blister
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
        Systemic - Chills
    14
    0
    4
    1
    8
    1
    3
    0
    6
    0
        Systemic - Diarrhea
    10
    1
    2
    1
    2
    1
    1
    0
    2
    0
        Systemic - Fatigue
    21
    3
    18
    5
    24
    1
    8
    1
    20
    1
        Systemic - Feeling hot
    11
    0
    7
    2
    8
    1
    10
    3
    15
    1
        Systemic - Headache
    23
    4
    21
    2
    20
    2
    22
    5
    23
    0
        Systemic - Hyperhidrosis
    11
    0
    1
    0
    3
    1
    4
    0
    7
    1
        Systemic - Joint swelling
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        Systemic - Myalgia
    12
    2
    8
    1
    2
    0
    3
    0
    10
    0
        Systemic - Nausea
    10
    1
    3
    2
    3
    0
    3
    0
    9
    0
        Systemic - Pyrexia
    5
    0
    1
    0
    0
    0
    4
    0
    1
    0
        Systemic - Rash
    1
    1
    2
    2
    1
    1
    2
    1
    2
    0
    No statistical analyses for this end point

    Primary: Number of participants with arthralgia, blister, joint swelling, pyrexia or rash following V920 vaccination

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    End point title
    		 Number of participants with arthralgia, blister, joint swelling, pyrexia or rash following V920 vaccination [2]
    End point description
    The number of participants with the following solicited systemic adverse events following vaccination: arthralgia, blister, joint swelling, pyrexia or rash.
    End point type
    Primary
    End point timeframe
    From vaccine administration up to 42 days post-vaccination
    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: The analyses for this endpoint were descriptive only, based on counts and percentages. No statistical testing was performed.
    End point values
    		 Cohort 1: V920 Cohort 1: Placebo Cohort 2: V920 Cohort 2: Placebo Cohort 3: V920 Cohort 3: Placebo Cohort 4: V920 Cohort 4: Placebo Cohort 5: V920 Cohort 5: Placebo
    Number of subjects analysed
    40
    10
    40
    10
    41
    9
    40
    10
    40
    10
    Units: Participants
        Arthralgia
    9
    2
    15
    2
    6
    0
    0
    0
    6
    1
        Blister
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
        Joint swelling
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
        Pyrexia
    8
    0
    2
    0
    1
    0
    7
    0
    3
    0
        Rash
    0
    1
    2
    0
    0
    0
    2
    0
    2
    0
    No statistical analyses for this end point

    Primary: Number of participants with unsolicited adverse events following V920 vaccination

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    End point title
    		 Number of participants with unsolicited adverse events following V920 vaccination [3]
    End point description
    The number of participants with unsolicited adverse events following vaccination.
    End point type
    Primary
    End point timeframe
    From vaccine administration up to day 42 post-vaccination
    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: The analyses for this endpoint were descriptive only, based on counts and percentages. No statistical testing was performed.
    End point values
    		 Cohort 1: V920 Cohort 1: Placebo Cohort 2: V920 Cohort 2: Placebo Cohort 3: V920 Cohort 3: Placebo Cohort 4: V920 Cohort 4: Placebo Cohort 5: V920 Cohort 5: Placebo
    Number of subjects analysed
    40
    10
    40
    10
    41
    9
    40
    10
    40
    10
    Units: Participants
        Blood & lymphatic system disorders-Lymphadenopathy
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Cardiac disorders - Angina pectoris
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Ear and labyrinth disorders - Cerumen impaction
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        Eye disorders - Conjunctivitis allergic
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
        Eye irritation
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        Eye disorders - Eye pain
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        Gastrointestinal disorders - Abdominal pain
    1
    0
    0
    0
    0
    0
    1
    1
    1
    0
        Gastrointestinal disorders - Abdominal pain upper
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
        Gastrointestinal disorders - Dental caries
    1
    1
    0
    0
    1
    0
    1
    0
    1
    0
        Gastrointestinal disorders - Diarrhea
    4
    1
    0
    0
    1
    0
    0
    0
    0
    1
        Gastrointestinal disorders - Dyspepsia
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Gastrointestinal disorders - Gastroduodenal ulcer
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Gastrointestinal disorders - Malpositioned teeth
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Gastrointestinal disorders - Oral papule
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Gastrointestinal disorders - Peptic ulcer
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        Gastrointestinal disorders - Toothache
    0
    0
    2
    0
    0
    0
    2
    0
    1
    0
        Chest pain
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        Fatigue
    0
    2
    1
    0
    1
    0
    0
    0
    0
    0
        Ill defined disorder
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
        Injection site induration
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Pain
    0
    0
    2
    1
    1
    0
    0
    0
    0
    0
        Tenderness
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Amoebic dysentery
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        Bronchitis
    1
    1
    0
    0
    2
    2
    2
    0
    1
    0
        Conjunctivitis bacterial
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        Cutaneous leishmaniasis
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        Cystitis
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Furuncle
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
        Gastroenteritis
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
        Influenza
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
        Malaria
    5
    1
    1
    0
    1
    0
    4
    1
    2
    0
        Nasopharyngitis
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
        Orchitis
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        Otitis media chronic
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
        Parasitic gastroenteritis
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Paronychia
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        Pilonidal disease
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Pneumonia
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Rhinitis
    0
    0
    3
    0
    4
    1
    2
    0
    3
    0
        Sinobronchitis
    0
    0
    1
    0
    4
    1
    3
    0
    1
    0
        Tinea pedis
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Tonsillitis
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Tooth abscess
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Tooth infection
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
        Typhoid fever
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Upper respiratory tract infection
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Urinary tract infection
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Vulvovaginal mycotic infection
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Ankle fracture
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Limb injury
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
        Thermal burn
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        Decreased appetite
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
        Back pain
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
        Bursitis
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Myalgia
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        Pain in extremity
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Torticollis
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
        Burning sensation
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Carpal tunnel syndrome
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Dizziness
    0
    0
    4
    0
    3
    0
    1
    0
    0
    1
        Headache
    1
    0
    3
    0
    2
    0
    1
    1
    3
    0
        Cervicobrachial syndrome
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        Intercostal neuralgia
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Paraesthesia
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
        Sciatica
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        Insomnia
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
        Breast pain
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Dysmenorrhoea
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
        Heavy menstrual bleeding
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        Vaginal discharge
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Bronchopneumopathy
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        Cough
    2
    0
    0
    0
    0
    1
    5
    1
    3
    1
        Lung disorder
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
        Oropharyngeal pain
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        Acne
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Ecchymosis
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hyperhidrosis
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Intertrigo
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Prurigo
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
        Pruritus
    3
    1
    0
    1
    0
    0
    1
    0
    1
    1
        Diastolic hypertension
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
        Hypertension
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
        Gastrointestinal Disorder
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Conjunctivitis
    0
    0
    1
    0
    0
    1
    2
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Serious Adverse Events Following V920 Vaccination

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    End point title
    		 Number of Participants With Serious Adverse Events Following V920 Vaccination [4]
    End point description
    The number of participants with vaccine-related serious adverse events following V920 vaccination.
    End point type
    Primary
    End point timeframe
    From vaccine administration up to day 365 following vaccination
    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: The analyses for this endpoint were descriptive only, based on counts and percentages. No statistical testing was performed.
    End point values
    		 Cohort 1: V920 Cohort 1: Placebo Cohort 2: V920 Cohort 2: Placebo Cohort 3: V920 Cohort 3: Placebo Cohort 4: V920 Cohort 4: Placebo Cohort 5: V920 Cohort 5: Placebo
    Number of subjects analysed
    40
    10
    40
    10
    41
    9
    40
    10
    40
    10
    Units: Participants
    2
    0
    0
    0
    1
    0
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Geometric Mean Titers Induced by V920

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    End point title
    		 Geometric Mean Titers Induced by V920
    End point description
    Geometric Mean Titers (GMTs) for ZEBOV-specific antibodies at Day 28 were calculated for each treatment group, along with two-sided 95% CIs, by exponentiating the corresponding log-transformed mean and two-sided 95% confidence limits. Cohorts 1-5.
    End point type
    Primary
    End point timeframe
    Day 28 postvaccination
    End point values
    		 Cohort 1: V920 Cohort 1: Placebo Cohort 2: V920 Cohort 2: Placebo Cohort 3: V920 Cohort 3: Placebo Cohort 4: V920 Cohort 4: Placebo Cohort 5: V920 Cohort 5: Placebo
    Number of subjects analysed
    40
    10
    40
    10
    41
    9
    40
    10
    40
    10
    Units: Titer
        geometric mean (confidence interval 95%)
    1655.0 (1151.4 to 2378.9)
    18.1 (8.7 to 37.3)
    1124.6 (821.0 to 1540.4)
    26.8 (13.8 to 52.0)
    868.8 (679.0 to 1111.6)
    29.7 (17.5 to 50.2)
    1432.8 (1091.0 to 1881.8)
    30.4 (17.6 to 52.4)
    1191.8 (865.7 to 1640.6)
    43.1 (22.8 to 81.8)
    Statistical analysis title
    		 GMTs for ZEBOV-specific antibodies
    Statistical analysis description
    Geometric Mean Titers (GMTs) for ZEBOV-specific antibodies at Day 28 were calculated for each treatment group, cohorts 1-5 combined, along with two-sided 95% CIs. Mean fold difference between treatment groups was compared using ANOVA.
    Comparison groups
    Cohort 1: V920 v Cohort 1: Placebo v Cohort 2: V920 v Cohort 2: Placebo v Cohort 3: V920 v Cohort 3: Placebo v Cohort 4: V920 v Cohort 4: Placebo v Cohort 5: V920 v Cohort 5: Placebo
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Fold difference
    Point estimate
    42.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 31.49
         upper limit
    		 58.43

    Primary: Geometric Mean Titers Induced by V920 in Cohort 5

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    End point title
    		 Geometric Mean Titers Induced by V920 in Cohort 5 [5]
    End point description
    Geometric Mean Titers (GMTs) for ZEBOV-specific antibodies at Day 28 were calculated for each treatment group, along with two-sided 95% CIs, by exponentiating the corresponding log-transformed mean and two-sided 95% confidence limits. Only Cohort 5 received 2 doses of vaccine.
    End point type
    Primary
    End point timeframe
    28 days after LAST (second) dose of vaccine
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analyses for this endpoint included only Cohort 5 (the Cohort that received 2 doses of study product).
    End point values
    		 Cohort 5: V920 Cohort 5: Placebo
    Number of subjects analysed
    40
    10
    Units: Titer
        geometric mean (confidence interval 95%)
    8416.0 (6461.9 to 10961.1)
    40.3 (23.8 to 68.4)
    Statistical analysis title
    		 GMTs for ZEBOV-specific antibodies (Cohort 5)
    Statistical analysis description
    Geometric Mean Titers (GMTs) for ZEBOV-specific antibodies at Day 28 following the second vaccination (day 84 post-vaccination 1) were calculated for each treatment group in cohort 5, along with two-sided 95% CIs. Mean fold difference between treatment groups was compared using ANOVA.
    Comparison groups
    Cohort 5: V920 v Cohort 5: Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANOVA
    Parameter type
    		 Fold difference
    Point estimate
    208.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 115.57
         upper limit
    		 376.72

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events reported in this section are collected through 1-year post-vaccination. Non-serious Adverse Events reported in this section are collected through 42 days post-vaccination.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Cohort 1: V920
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥ 500 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 1: Placebo
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥500 randomly assigned to receive placebo.

    Reporting group title
    Cohort 2: V920
    Reporting group description
    		 Adults with screening CD4 cells/mm3 >350 and <500 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 2: Placebo
    Reporting group description
    		 Adults with screening CD4 cells/mm3 >350 and <500 randomly assigned to receive placebo.

    Reporting group title
    Cohort 3: V920
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥200 and ≤350 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 3: Placebo
    Reporting group description
    		 Adults with screening CD4 cells/mm3 ≥200 and ≤350 randomly assigned to receive placebo.

    Reporting group title
    Cohort 4: V920
    Reporting group description
    		 Adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine.

    Reporting group title
    Cohort 4: Placebo
    Reporting group description
    		 Adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive placebo.

    Reporting group title
    Cohort 5: V920
    Reporting group description
    		 Adults and adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive ≥2 x 107 pfu of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine. This cohort received 2 doses 56 days apart.

    Reporting group title
    Cohort 5: Placebo
    Reporting group description
    		 Adults and adolescents with screening CD4 cells/mm3 ≥200 randomly assigned to receive placebo. This cohort received 2 doses 56 days apart.

    Serious adverse events
    		 Cohort 1: V920 Cohort 1: Placebo Cohort 2: V920 Cohort 2: Placebo Cohort 3: V920 Cohort 3: Placebo Cohort 4: V920 Cohort 4: Placebo Cohort 5: V920 Cohort 5: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    1 / 41 (2.44%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    1 / 41 (2.44%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    1 / 41 (2.44%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis toxic
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pseudarthrosis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cohort 1: V920 Cohort 1: Placebo Cohort 2: V920 Cohort 2: Placebo Cohort 3: V920 Cohort 3: Placebo Cohort 4: V920 Cohort 4: Placebo Cohort 5: V920 Cohort 5: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 40 (62.50%)
    5 / 10 (50.00%)
    11 / 40 (27.50%)
    4 / 10 (40.00%)
    8 / 41 (19.51%)
    5 / 9 (55.56%)
    20 / 40 (50.00%)
    4 / 10 (40.00%)
    13 / 40 (32.50%)
    4 / 10 (40.00%)
    Injury, poisoning and procedural complications
    Limb injury
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    2 / 40 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Vascular disorders
    Diastolic hypertension
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Cervicobrachial syndrome
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Sciatica
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Dizziness
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    4 / 40 (10.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    4
    0
    0
    0
    0
    0
    0
    1
    Headache
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    3 / 40 (7.50%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    3 / 40 (7.50%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    1
    3
    0
    General disorders and administration site conditions
    Diarrhoea
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    4 / 40 (10.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    4
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Fatigue
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    6 / 40 (15.00%)
    2 / 10 (20.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    6
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Pain
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    2 / 40 (5.00%)
    1 / 10 (10.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    Ill-defined disorder
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    2 / 40 (5.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Gastrointestinal disorders
    Toothache
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    2 / 40 (5.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Gastroenteritis
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Abdominal pain
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    5 / 40 (12.50%)
    1 / 10 (10.00%)
    3 / 40 (7.50%)
    1 / 10 (10.00%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    5
    1
    3
    1
    Bronchopneumopathy
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    0
    1
    0
    0
    0
    0
    0
    1
    Psychiatric disorders
    Insomnia
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Back pain
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    1 / 9 (11.11%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Malaria
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    5 / 40 (12.50%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    4 / 40 (10.00%)
    1 / 10 (10.00%)
    2 / 40 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    5
    1
    0
    0
    0
    0
    4
    1
    2
    0
    Nasopharyngitis
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Bronchitis
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    2 / 40 (5.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    0
    0
    0
    Conjunctivitis
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    2 / 40 (5.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    Influenza
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Rhinitis
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    4 / 41 (9.76%)
    1 / 9 (11.11%)
    2 / 40 (5.00%)
    0 / 10 (0.00%)
    3 / 40 (7.50%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    1
    2
    0
    3
    0
    Sinobronchitis
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    4 / 41 (9.76%)
    1 / 9 (11.11%)
    3 / 40 (7.50%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    1
    3
    0
    0
    0
    Otitis media chronic
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    1 / 10 (10.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
    Additional description: Non-serious Adverse Events through to 42 days post-vaccination
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 41 (0.00%)
    0 / 9 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
    0 / 40 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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