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    Clinical Trial Results:
    A multicenter, randomized, double-blind, active-controlled phase IIb trial as part of the EU-funded UNISEC project to assess the immunogenicity and safety of a BiondVax-developed influenza vaccine (Multimeric-001) followed by an administration of H5N1 influenza vaccine, administered intramuscularly in healthy adults aged 18-60 years.

    Summary
    EudraCT number
    		 2015-001979-46
    Trial protocol
    		 HU  
    Global end of trial date
    12 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jan 2019
    First version publication date
    10 Jan 2019
    Other versions
    Summary report(s)
    		 Summary BVX-007

    Trial information

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    Trial identification
    Sponsor protocol code
    BVX-007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02691130
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BiondVax Pharmaceuticals Ltd
    Sponsor organisation address
    Hadassah Hospital, BJP bldg, Jerusalem, Israel,
    Public contact
    local representative in Hungary, SanaClis s.r.o., +36 209760341, beata.balati@invitel.hu
    Scientific contact
    Dr Ben Yedidia, CSO, BiondVax Pharmaceuticals Ltd, +972 89302529, benyedidia@biondvax.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
    12 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the immunogenicity and safety of M-001 in healthy adults.
    Protection of trial subjects
    A medical monitor was assigned by the sponsor: Prof. Shai Ashkenazi, M.D. M.sc. at Schneider Children’s Medical Center of Israel, who reviewed the MedDRA coding of all adverse events reported during the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Oct 2015
    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
    Hungary: 224
    Worldwide total number of subjects
    224
    EEA total number of subjects
    224
    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)
    224
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 224 healthy participants aged 18-60 years old were assigned to the trial.

    Pre-assignment
    Screening details
    		 Inclusion criteria: -Healthy male or non-pregnant female aged 18-60 years -Women of childbearing potential and men must agree to practice adequate contraception - Is in good health - Able to understand and comply with study procedures -signs informed consent

    Pre-assignment period milestones
    Number of subjects started
    		 224
    Number of subjects completed
    		 224

    Period 1
    Period 1 title
    Baseline (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 is double-blinded. To maintain blinding, the preparation of the IMP and control was performed by an unblinded Qualified Person other than the person giving the injection since the prepared IMP and control (saline) differ in appearance. The syringe content was hidden by a label, including the necessary trial randomization information. Only the unblinded study pharmacist/prepared the dosing and used the study randomization code to assign each subject to the appropriate treatment group

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 M-001 High
    Arm description
    		 2 administrations of M-001 at a dose of 1mg, experimental treatment group
    Arm type
    		 Experimental

    Investigational medicinal product name
    M-001
    Investigational medicinal product code
    Other name
    Multimeric-001
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5mg (Low) or 1.0mg (High) per dose

    Arm title
    		 M-001 Low
    Arm description
    		 2 administrations of M-001 at a dose of 0.5mg, experimental treatment group
    Arm type
    		 Experimental

    Investigational medicinal product name
    M-001
    Investigational medicinal product code
    Other name
    Multimeric-001
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5mg per dose

    Arm title
    		 Placebo
    Arm description
    		 Saline Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5mL per IM injection

    Number of subjects in period 1
    		M-001 High M-001 Low Placebo
    Started
    74
    75
    75
    Completed
    74
    75
    75

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    M-001 High
    Reporting group description
    		 2 administrations of M-001 at a dose of 1mg, experimental treatment group

    Reporting group title
    M-001 Low
    Reporting group description
    		 2 administrations of M-001 at a dose of 0.5mg, experimental treatment group

    Reporting group title
    Placebo
    Reporting group description
    		 Saline Placebo

    Reporting group values
    		 M-001 High M-001 Low Placebo Total
    Number of subjects
    		 74 75 75 224
    Age categorical
    18-60 years old
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
        18-60
    		 74 75 75 224
    Gender categorical
    Units: Subjects
        Female
    		 51 47 46 144
        Male
    		 23 28 29 80
    Subject analysis sets

    Subject analysis set title
    High Dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All the subjects were analyzed for all endpoints

    Subject analysis set title
    Low Dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All the subjects were analyzed for all endpoints

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All the subjects were analyzed for all endpoints

    Subject analysis sets values
    		 High Dose Low Dose Placebo
    Number of subjects
    74
    75
    75
    Age categorical
    18-60 years old
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    0
    0
    0
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
        18-60
    74
    75
    75
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    M-001 High
    Reporting group description
    		 2 administrations of M-001 at a dose of 1mg, experimental treatment group

    Reporting group title
    M-001 Low
    Reporting group description
    		 2 administrations of M-001 at a dose of 0.5mg, experimental treatment group

    Reporting group title
    Placebo
    Reporting group description
    		 Saline Placebo

    Subject analysis set title
    High Dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All the subjects were analyzed for all endpoints

    Subject analysis set title
    Low Dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All the subjects were analyzed for all endpoints

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All the subjects were analyzed for all endpoints

    Primary: safety

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    End point title
    		 safety
    End point description
    To evaluate the number of participants with related solicited AEs in all subjects until 21 days after the last dosing of the study vaccine (M-001)
    End point type
    Primary
    End point timeframe
    Day 0-42
    End point values
    		 M-001 High M-001 Low Placebo High Dose Low Dose Placebo
    Number of subjects analysed
    74
    75
    75
    74
    75
    75
    Units: Number and severity of adverse events
    74
    75
    75
    74
    75
    75
    Statistical analysis title
    		 Safety in treatment vs control group
    Comparison groups
    M-001 High v M-001 Low v Placebo
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: Immunogenicity

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    End point title
    		 Immunogenicity
    End point description
    To evaluate the absolute proportions of responders with CD4+ T cells that produce any Th1 cytokines based on multiparametric FACS analysis in all groups on day 0 and 42
    End point type
    Primary
    End point timeframe
    0-42
    End point values
    		 M-001 High M-001 Low Placebo
    Number of subjects analysed
    74
    75
    75
    Units: % responders
    74
    75
    75
    Statistical analysis title
    		 % responders with CD4+ TH1 response
    Statistical analysis description
    Absolute proportions of responders with CD4+ T cells that produce any Th1 cytokines after 2 immunizations in the experimental and control groups.
    Comparison groups
    M-001 High v M-001 Low v Placebo
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    180 days post second immunization
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    High Dose
    Reporting group description
    		 -

    Reporting group title
    Low Dose
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 High Dose Low Dose Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 75 (0.00%)
    1 / 75 (1.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Reproductive system and breast disorders
    Vaginal prolapse
    Additional description: Unrelated to treatment
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 High Dose Low Dose Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 74 (6.76%)
    2 / 75 (2.67%)
    4 / 75 (5.33%)
    General disorders and administration site conditions
    Pain of skin
    Additional description: Mild severity of pain in the administration site immediately after IM injection that is definitely related to the treatment
         subjects affected / exposed
    2 / 74 (2.70%)
    1 / 75 (1.33%)
    1 / 75 (1.33%)
         occurrences all number
    2
    1
    1
    Erythema
    Additional description: Mild Erythema that is definitely related to the treatment
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 75 (0.00%)
    2 / 75 (2.67%)
         occurrences all number
    0
    0
    2
    Induration
    Additional description: Moderate induration that is definitely related to the treatment
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 75 (0.00%)
    1 / 75 (1.33%)
         occurrences all number
    1
    0
    1
    Swelling
    Additional description: Mild swelling that is definitely related to the treatment
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 75 (1.33%)
    0 / 75 (0.00%)
         occurrences all number
    1
    1
    0
    warmth
    Additional description: Mild warmth that is definitely related to the treatment
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
         occurrences all number
    1
    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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