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    Clinical Trial Results:
    Efficacy of MVA-NP+M1 in the influenza H3N2 Human Challenge model

    Summary
    EudraCT number
    		 2018-004015-49
    Trial protocol
    		 BE  
    Global end of trial date
    17 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Dec 2020
    First version publication date
    23 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FLU010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03883113
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vaccitech Ltd
    Sponsor organisation address
    The Schrödinger Building, Heatley Road, The Oxford Science Park, Oxford, United Kingdom, OX4 4GE
    Public contact
    Chris Ellis, Vaccitech Ltd, enquiries@vaccitech.co.uk
    Scientific contact
    Tom Evans, MD, Vaccitech Ltd, tom.evans@vaccitech.co.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to show that MVA-NP+M1 decreases the viral shedding of influenza virus, as measured by the cumulative area under the curve, following human challenge.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Note for Guidance on Good Clinical Practice (GCP) (CPMP/ICH/135/95) and with applicable local requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 145
    Worldwide total number of subjects
    145
    EEA total number of subjects
    145
    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)
    145
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at the SGS Clinical Pharmacology Unit in Antwerp, Belgium

    Pre-assignment
    Screening details
    		 Eight-hundred and nineteen (819) subjects were screened. One hundred and forty-five (145) subjects were actually enrolled and vaccinated. The study consisted of an outpatient vaccination phase and at least 6 weeks later an inpatient challenge phase.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Since MVA-NP+M1 has a cloudy appearance compared to saline Placebo, a label surrounded the syringes to maintain the blind. The syringes were transported from the pharmacy to the vaccination room in opaque containers to keep the study treatment blinded from the site staff and the study participants. The dedicated unblinded dosing team was assigned for the vaccine administration. The participant receiving the placebo was asked to look away from the injection site to keep the blind

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MVA-NP+M1
    Arm description
    		 MVA-NP+M1 & H3N2 Challenge
    Arm type
    		 Experimental

    Investigational medicinal product name
    MVA-NP+M1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of MVA-NP+M1 at 1.5 x 10E8 plaque forming unit, 0,5 mL given intramuscularly in the deltoid.

    Arm title
    		 Placebo
    Arm description
    		 Placebo & H3N2 Challenge
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Saline Placebo 0,5 mL given intramuscularly in the deltoid.

    Number of subjects in period 1
    		MVA-NP+M1 Placebo
    Started
    87
    58
    Completed
    71
    46
    Not completed
    16
    12
         Physician decision
    4
    2
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    -
    1
         Other
    9
    7
         Pregnancy
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MVA-NP+M1
    Reporting group description
    		 MVA-NP+M1 & H3N2 Challenge

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo & H3N2 Challenge

    Reporting group values
    		 MVA-NP+M1 Placebo Total
    Number of subjects
    		 87 58 145
    Age categorical
    Units: Subjects
        Adults (18-55 years)
    		 87 58 145
    Age continuous
    Units: years
        median (full range (min-max))
    		 43.00 (18.5 to 55.9) 41.25 (19.9 to 55.7) -
    Gender categorical
    Units: Subjects
        Female
    		 47 31 78
        Male
    		 40 27 67
    Race
    Units: Subjects
        Asian
    		 2 0 2
        Black or African American
    		 4 0 4
        Middle Eastern
    		 0 1 1
        White
    		 81 57 138
    Smoking status
    Units: Subjects
        Ex-smoker
    		 27 18 45
        Non-smoker
    		 60 40 100
    Height
    Units: cm
        median (full range (min-max))
    		 172.40 (153.2 to 193.3) 172.30 (151.8 to 191.7) -
    Weight
    Units: kg
        median (full range (min-max))
    		 72.90 (53.2 to 118.8) 75.15 (54.6 to 105.6) -
    BMI
    Units: kg/m2
        median (full range (min-max))
    		 24.70 (19.0 to 32.0) 25.50 (19.2 to 31.2) -

    End points

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    End points reporting groups
    Reporting group title
    MVA-NP+M1
    Reporting group description
    		 MVA-NP+M1 & H3N2 Challenge

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo & H3N2 Challenge

    Subject analysis set title
    MVA-NP+M1 (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Efficacy

    Subject analysis set title
    Placebo (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Efficacy

    Subject analysis set title
    MVA-NP+M1 (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Efficacy

    Subject analysis set title
    Placebo (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Efficacy

    Subject analysis set title
    MVA-NP+M1 (Challenge)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety

    Subject analysis set title
    Placebo (Challenge)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety

    Primary: Efficacy: Viral shedding AUC (qRT-PCR)

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    End point title
    		 Efficacy: Viral shedding AUC (qRT-PCR)
    End point description
    End point type
    Primary
    End point timeframe
    9 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT) MVA-NP+M1 (PP) Placebo (PP) MVA-NP+M1 (Challenge) Placebo (Challenge)
    Number of subjects analysed
    71
    47
    70
    47
    71
    47
    Units: subjects
        least squares mean (confidence interval 95%)
    649.7 (552.7 to 746.7)
    726.1 (604.0 to 848.2)
    646.5 (548.3 to 744.7)
    726.1 (604.0 to 848.2)
    649.7 (552.7 to 746.7)
    726.1 (604.0 to 848.2)
    Statistical analysis title
    		 Viral Shedding AUC (qRT-PCR)
    Comparison groups
    MVA-NP+M1 (ITT) v Placebo (ITT)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1711
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Viral Shedding AUC (qRT-PCR)
    Comparison groups
    MVA-NP+M1 (PP) v Placebo (PP)
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1654
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Viral Shedding AUC (qRT-PCR)
    Comparison groups
    MVA-NP+M1 (Challenge) v Placebo (Challenge)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1711
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Efficacy: qPCR Attack Rate (qRT-PCR)

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    End point title
    		 Efficacy: qPCR Attack Rate (qRT-PCR)
    End point description
    End point type
    Secondary
    End point timeframe
    9 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    71
    47
    Units: Percentage
    number (confidence interval 95%)
        qPCR-confirmed influenza
    90.1 (80.7 to 95.9)
    97.9 (88.7 to 99.9)
        No qPCR-confirmed influenza
    9.9 (4.1 to 19.3)
    2.1 (0.1 to 11.3)
    Statistical analysis title
    		 qPCR Attack Rate
    Comparison groups
    MVA-NP+M1 (ITT) v Placebo (ITT)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.143
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Efficacy: Culture Attack Rate (qCulture)

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    End point title
    		 Efficacy: Culture Attack Rate (qCulture)
    End point description
    End point type
    Secondary
    End point timeframe
    9 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    71
    47
    Units: Percentage
    number (confidence interval 95%)
        Culture-confirmed influenza
    77.5 (66.0 to 86.5)
    85.1 (71.7 to 93.8)
        No Culure-confirmed
    22.5 (13.5 to 34.0)
    14.9 (6.2 to 28.3)
    Statistical analysis title
    		 Culture Attack Rate
    Comparison groups
    MVA-NP+M1 (ITT) v Placebo (ITT)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3504
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Efficacy: Time to Start of Viral Shedding (qPCR)

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    End point title
    		 Efficacy: Time to Start of Viral Shedding (qPCR)
    End point description
    End point type
    Secondary
    End point timeframe
    11 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    71 [1]
    47 [2]
    Units: Percentage
        median (confidence interval 95%)
    24.40 (24.30 to 24.50)
    24.30 (24.20 to 24.50)
    Notes
    [1] - subjects assessed = 71 subjects with event = 64 subjects censored = 7
    [2] - subjects assessed = 47 subjects with event = 46 subjects censored = 1
    Statistical analysis title
    		 Time to Start of Viral Shedding
    Comparison groups
    MVA-NP+M1 (ITT) v Placebo (ITT)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5558
    Method
    		 Logrank
    Confidence interval

    Secondary: Efficacy: Time to Start of Viral Shedding (qCulture)

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    End point title
    		 Efficacy: Time to Start of Viral Shedding (qCulture)
    End point description
    End point type
    Secondary
    End point timeframe
    9 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    71 [3]
    47 [4]
    Units: Subjects
        median (confidence interval 95%)
    35.90 (35.60 to 48.00)
    47.60 (24.70 to 48.50)
    Notes
    [3] - Subjects assessed = 71 Subjects with event = 55 Subjects censored = 16
    [4] - Subjects assessed = 47 Subjects with event = 40 Subjects censored = 7
    Statistical analysis title
    		 Time to Start Viral Shedding (qCulture)
    Comparison groups
    MVA-NP+M1 (ITT) v Placebo (ITT)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6534
    Method
    		 Logrank
    Confidence interval

    Secondary: Efficacy: Peak Viral Shedding (qPCR)

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    End point title
    		 Efficacy: Peak Viral Shedding (qPCR)
    End point description
    End point type
    Secondary
    End point timeframe
    9 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    64
    46
    Units: Subjects
        arithmetic mean (confidence interval 95%)
    5.876 (5.430 to 6.322)
    6.054 (5.521 to 6.587)
    Statistical analysis title
    		 Peak Viral Shedding
    Comparison groups
    MVA-NP+M1 (ITT) v Placebo (ITT)
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5485
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Efficacy: Peak Viral Shedding (qCulture)

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    End point title
    		 Efficacy: Peak Viral Shedding (qCulture)
    End point description
    End point type
    Secondary
    End point timeframe
    9 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    55
    40
    Units: Subjects
        arithmetic mean (confidence interval 95%)
    4.073 (3.683 to 4.463)
    4.069 (3.442 to 4.695)
    Statistical analysis title
    		 Peak Viral Shedding
    Comparison groups
    MVA-NP+M1 (ITT) v Placebo (ITT)
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6753
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Efficacy: Time to Peak Viral Shedding (qPCR)

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    End point title
    		 Efficacy: Time to Peak Viral Shedding (qPCR)
    End point description
    End point type
    Secondary
    End point timeframe
    9 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    71 [5]
    47 [6]
    Units: Subjects
        median (confidence interval 95%)
    72.20 (60.00 to 96.00)
    107.90 (72.20 to 119.80)
    Notes
    [5] - Subjects assessed = 71 Subjects with event = 64 Subjects censored = 7
    [6] - Subjects assessed = 47 Subjects with event = 46 Subjects censored = 1
    Statistical analysis title
    		 Time to Peak of Viral Shedding
    Comparison groups
    Placebo (ITT) v MVA-NP+M1 (ITT)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.711
    Method
    		 Logrank
    Confidence interval

    Secondary: Efficacy: Time to Peak Viral Shedding (qCulture)

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    End point title
    		 Efficacy: Time to Peak Viral Shedding (qCulture)
    End point description
    End point type
    Secondary
    End point timeframe
    9 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    71 [7]
    47 [8]
    Units: Subjects
        median (confidence interval 95%)
    83.40 (60.10 to 96.30)
    83.80 (60.10 to 96.40)
    Notes
    [7] - Subjects assessed = 71 Subjects with event = 55 Subjects censored = 16
    [8] - Subjects assessed = 47 Subjects with event = 40 Subjects censored = 7
    Statistical analysis title
    		 Time to Peak of Viral Shedding (qCulture)
    Comparison groups
    MVA-NP+M1 (ITT) v Placebo (ITT)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4689
    Method
    		 Logrank
    Confidence interval

    Secondary: Efficacy: Duration of Viral Shedding (qPCR)

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    End point title
    		 Efficacy: Duration of Viral Shedding (qPCR)
    End point description
    End point type
    Secondary
    End point timeframe
    11 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    64
    46
    Units: Days
        arithmetic mean (confidence interval 95%)
    170.80 (157.08 to 184.52)
    172.47 (156.99 to 187.94)
    No statistical analyses for this end point

    Secondary: Efficacy: Duration of Viral Shedding (qCulture)

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    End point title
    		 Efficacy: Duration of Viral Shedding (qCulture)
    End point description
    End point type
    Secondary
    End point timeframe
    11 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    55
    40
    Units: Days
        arithmetic mean (confidence interval 95%)
    118.19 (105.07 to 131.31)
    121.78 (106.33 to 137.23)
    No statistical analyses for this end point

    Secondary: Efficacy: AUC Composite Symptom Score

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    End point title
    		 Efficacy: AUC Composite Symptom Score
    End point description
    End point type
    Secondary
    End point timeframe
    11 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    71
    47
    Units: Composite Symptom Score
        geometric mean (confidence interval 95%)
    16.709 (11.568 to 21.850)
    20.432 (13.753 to 27.112)
    Statistical analysis title
    		 AUC of the Composite Symptom Score
    Comparison groups
    MVA-NP+M1 (ITT) v Placebo (ITT)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Efficacy: Total Number of Days of Fever

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    End point title
    		 Efficacy: Total Number of Days of Fever
    End point description
    End point type
    Secondary
    End point timeframe
    11 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    71
    47
    Units: Days
        arithmetic mean (confidence interval 95%)
    0.0 (0.0 to 0.1)
    0.0 (0.0 to 0.1)
    Statistical analysis title
    		 Total Number of Days of Fever
    Comparison groups
    MVA-NP+M1 (ITT) v Placebo (ITT)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6799
    Method
    		 zero-inflated poisson model
    Confidence interval

    Secondary: Efficacy: Total Mucus Production

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    End point title
    		 Efficacy: Total Mucus Production
    End point description
    End point type
    Secondary
    End point timeframe
    11 days
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    26
    18
    Units: Total Mucus Production
        arithmetic mean (confidence interval 95%)
    31.09 (16.33 to 45.85)
    38.21 (16.78 to 59.63)
    Statistical analysis title
    		 Total Mucus Production
    Comparison groups
    MVA-NP+M1 (ITT) v Placebo (ITT)
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5911
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: PD: Correlation Plots of T-Cell Responses (Elispot Results) to The Primary Endpoint, Symptom Scores and Influenza Incidence

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    End point title
    		 PD: Correlation Plots of T-Cell Responses (Elispot Results) to The Primary Endpoint, Symptom Scores and Influenza Incidence
    End point description
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 MVA-NP+M1 (ITT) Placebo (ITT)
    Number of subjects analysed
    71
    47 [9]
    Units: Subjects
    71
    47
    Attachments
    		 Correlation Plots of T Cell reponses
    Notes
    [9] - Challenge Day 28 = 46 subjects
    No statistical analyses for this end point

    Secondary: Summary TEAE and Solicited Symptoms (Vaccination Phase)

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    End point title
    		 Summary TEAE and Solicited Symptoms (Vaccination Phase)
    End point description
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 MVA-NP+M1 Placebo
    Number of subjects analysed
    87
    58
    Units: Subjects
        TEAE
    36
    18
        Solicited symptom
    84
    24
        TEAE or solicited symptom
    85
    34
        Local solicited symptom
    80
    8
        Local Grade 3 solicited symptom
    2
    0
        Systemic solicited symptom
    72
    20
        Systemic Grade 3 solicited symptom
    2
    0
        TEAE of special interest
    0
    0
        Serious TEAE
    1
    0
        Non-serious TEAE
    36
    18
        Grade ≥ 3 TEAE
    1
    0
        Grade ≥ 3 TE laboratory toxicity
    2
    0
        Fatal TEAE
    0
    0
        TEAE related to treatment
    10
    4
        Serious TEAE related to treatment
    1
    0
        Grade ≥ 3 TEAE related to treatment
    1
    0
        TEAE for which study was discontinued
    0
    0
    No statistical analyses for this end point

    Secondary: Summary TEAE and Solicited Symptoms (Challenge Phase)

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    End point title
    		 Summary TEAE and Solicited Symptoms (Challenge Phase)
    End point description
    End point type
    Secondary
    End point timeframe
    17 days
    End point values
    		 MVA-NP+M1 (Challenge) Placebo (Challenge)
    Number of subjects analysed
    71
    47
    Units: Subjects
        TEAE
    30
    21
        Solicited symptom
    62
    40
        TEAE or solicited symptom
    65
    42
        Local solicited symptom
    59
    39
        Local Grade 3 solicited symptom
    0
    0
        Systemic solicited symptom
    45
    32
        Sytemic Grade 3 solicited symptom
    0
    0
        TEAE of special interest
    0
    0
        Serious TEAE
    0
    1
        Non-serious TEAE
    30
    20
        Grade ≥3 TEAE
    0
    2
        Grade ≥3 TE laboratory toxicity
    7
    2
        Fatal TEAE
    0
    0
        TEAE related to challenge
    7
    5
        Serious TEAE related to challenge
    0
    0
        Grade ≥3 TEAE related to challenge
    0
    0
        TEAE for which study was discontinued
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAE) are defined as AEs starting during or after first administration of any study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    MVA-NP+M1 (Vaccination Phase)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Vaccination Phase)
    Reporting group description
    		 -

    Reporting group title
    MVA-NP+M1 (Challenge Phase)
    Reporting group description
    		 -

    Reporting group title
    Placebo (Challenge Phase)
    Reporting group description
    		 -

    Serious adverse events
    		 MVA-NP+M1 (Vaccination Phase) Placebo (Vaccination Phase) MVA-NP+M1 (Challenge Phase) Placebo (Challenge Phase)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    1 / 47 (2.13%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Foetal death
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MVA-NP+M1 (Vaccination Phase) Placebo (Vaccination Phase) MVA-NP+M1 (Challenge Phase) Placebo (Challenge Phase)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 87 (41.38%)
    18 / 58 (31.03%)
    30 / 71 (42.25%)
    21 / 47 (44.68%)
    Surgical and medical procedures
    Scar excision
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Inflammation
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 58 (0.00%)
    2 / 71 (2.82%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Throat irritation
         subjects affected / exposed
    3 / 87 (3.45%)
    2 / 58 (3.45%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    3
    2
    0
    0
    Epistaxis
         subjects affected / exposed
    3 / 87 (3.45%)
    0 / 58 (0.00%)
    2 / 71 (2.82%)
    0 / 47 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 58 (1.72%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Sneezing
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 58 (1.72%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dysphonia
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 58 (1.72%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Joint injury
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin wound
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Arthropod bite
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 58 (1.72%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ligament sprain
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 58 (1.72%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 87 (5.75%)
    2 / 58 (3.45%)
    2 / 71 (2.82%)
    1 / 47 (2.13%)
         occurrences all number
    5
    2
    2
    1
    Presyncope
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 58 (1.72%)
    2 / 71 (2.82%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Eye disorders
    Eye irritation
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    2 / 71 (2.82%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Lacrimation increased
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Swelling of eyelid
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 87 (5.75%)
    3 / 58 (5.17%)
    3 / 71 (4.23%)
    0 / 47 (0.00%)
         occurrences all number
    5
    3
    3
    0
    Nausea
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    0
    0
    0
    2
    Constipation
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dry mouth
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Regurgitation
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    3 / 87 (3.45%)
    1 / 58 (1.72%)
    2 / 71 (2.82%)
    0 / 47 (0.00%)
         occurrences all number
    3
    1
    2
    0
    Skin irritation
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 58 (1.72%)
    3 / 71 (4.23%)
    1 / 47 (2.13%)
         occurrences all number
    2
    1
    3
    1
    Dry skin
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    1
    1
    Eczema
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 87 (3.45%)
    0 / 58 (0.00%)
    4 / 71 (5.63%)
    6 / 47 (12.77%)
         occurrences all number
    4
    0
    4
    6
    Neck pain
         subjects affected / exposed
    2 / 87 (2.30%)
    1 / 58 (1.72%)
    0 / 71 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    2
    1
    0
    1
    Bursitis
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Flank pain
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 87 (6.90%)
    4 / 58 (6.90%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    7
    4
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 87 (0.00%)
    2 / 58 (3.45%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Oral herpes
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
    1 / 47 (2.13%)
         occurrences all number
    2
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 87 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Apr 2019
    - Additional timepoints in challenge period to measure transcriptomics. Sodium and potassium tests were added to the biochemistry test in the challenge period. - The exclusion criteria were split in two categories i.e., study entry and challenge period entry. - The process that maintains the double blind throughout the study was amended to provide a robust procedure.
    17 Jul 2019
    - MNT increased from ≤10 to <20. - Attack rate change from 90% to 83%. - A clarification added the challenge risk section.

    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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