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    Clinical Trial Results:
    An Exploratory, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-Old Adults

    Summary
    EudraCT number
    		 2017-003194-33
    Trial protocol
    		 GB  
    Global end of trial date
    27 Nov 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Jul 2021
    First version publication date
    18 Dec 2019
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    VAC18193RSV2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03334695
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines and Prevention B.V.
    Sponsor organisation address
    Newtonweg 1, Leiden, Netherlands, 2333 CM
    Public contact
    Clinical Registry Group, Janssen Vaccines and Prevention B.V., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Vaccines and Prevention B.V., ClinicalTrialsEU@its.jnj.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
    27 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess a trend for the prophylactic efficacy of a single dose of 1*10^11 viral particles (vp) of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) administered intramuscularly (IM) to adults aged 18 to 50 years in the RSV challenge model in terms of the reduction of nasal wash viral load as measured by the area under the curve (AUC) over time by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) compared to placebo.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and applicable regulatory requirements. Safety was evaluated based on the following variables: adverse events (AEs), clinical laboratory tests (hematology, serum chemistry, and urinalysis), vital signs measurements, physical examinations and electrocardiograms (ECGs).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 63
    Worldwide total number of subjects
    63
    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)
    0
    Adults (18-64 years)
    63
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In total, 64 subjects were screened. Of these, 63 subjects were randomized and received the study vaccine. One subject was randomized in error and did not receive the study vaccine hence not included in the analyses.

    Period 1
    Period 1 title
    Overall Study (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
    		 Ad26.RSV.preF (1*10^11 vp)
    Arm description
    		 Subjects received a single intramuscular injection of 1*10^11 viral particles (vp) of Ad26.RSV.preF on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.RSV.preF
    Investigational medicinal product code
    Other name
    JNJ-64400141
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Ad26.RSV.preF was administered as an intramuscular injection.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received an intramuscular injection of matching placebo.

    Number of subjects in period 1
    		Ad26.RSV.preF (1*10^11 vp) Placebo
    Started
    31
    32
    Received Challenge
    27
    26
    Completed
    27
    26
    Not completed
    4
    6
         Physician decision
    1
    2
         Lost to follow-up
    3
    3
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ad26.RSV.preF (1*10^11 vp)
    Reporting group description
    		 Subjects received a single intramuscular injection of 1*10^11 viral particles (vp) of Ad26.RSV.preF on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0.

    Reporting group values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo Total
    Number of subjects
    		 31 32 63
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 31 32 63
        From 65 to 84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.9 ( 6.19 ) 25.9 ( 6.56 ) -
    Title for Gender
    Units: subjects
        Female
    		 12 6 18
        Male
    		 19 26 45

    End points

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    End points reporting groups
    Reporting group title
    Ad26.RSV.preF (1*10^11 vp)
    Reporting group description
    		 Subjects received a single intramuscular injection of 1*10^11 viral particles (vp) of Ad26.RSV.preF on Day -28 followed by intranasal challenge with a respiratory syncytial virus (RSV)-A Memphis 37b virus on Day 0.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a single intramuscular injection of matching placebo on Day -28 followed by intranasal challenge with RSV-A Memphis 37b virus on Day 0.

    Primary: Area Under the Viral Load-time Curve (VL-AUC) of RSV by Quantitative Reverse Transcriptase-polymerase Chain Reaction (qRT-PCR)

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    End point title
    		 Area Under the Viral Load-time Curve (VL-AUC) of RSV by Quantitative Reverse Transcriptase-polymerase Chain Reaction (qRT-PCR)
    End point description
    VL-AUC for RSV was determined by qRT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero. The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all subjects who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) including all randomized, vaccinated and challenged subjects.
    End point type
    Primary
    End point timeframe
    From Day 2 to Day 12
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    27
    26
    Units: log10 copies*hour per millilitre (h/mL)
        median (inter-quartile range (Q1-Q3))
    0 (0.0 to 268.8)
    236 (20.3 to 605.8)
    Statistical analysis title
    		 Statistical analysis
    Comparison groups
    Ad26.RSV.preF (1*10^11 vp) v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 Wilcoxon Rank Sum test
    Confidence interval

    Secondary: Peak Viral Load of RSV-A Memphis 37b

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    End point title
    		 Peak Viral Load of RSV-A Memphis 37b
    End point description
    Peak viral load of RSV-A Memphis 37b was defined as the maximum viral load by quantitative RT-PCR assay of nasal wash samples. Here, values below the lower limit of quantification (LLOQ) were imputed with zero. The ITTc population is a subset of the Full Analysis Set (FAS) (all subjects who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) including all randomized, vaccinated and challenged subjects.
    End point type
    Secondary
    End point timeframe
    From Day 2 and Day 12
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    27
    26
    Units: log10 copies per mL
        median (inter-quartile range (Q1-Q3))
    0.000 (0.000 to 4.539)
    5.365 (3.027 to 6.665)
    No statistical analyses for this end point

    Secondary: Viral Load by Quantitative RT-PCR Assay on Day 6 and 7

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    End point title
    		 Viral Load by Quantitative RT-PCR Assay on Day 6 and 7
    End point description
    Viral load determined by quantitative RT-PCR assay of nasal wash samples on Day 6 and Day 7 were reported. Here, values below the lower limit of quantification (LLOQ) were imputed with zero. The ITTc population is a subset of the FAS (all subjects who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) including all randomized, vaccinated and challenged subjects. Here 'n' (number of subjects analyzed) signifies the number of subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours)
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    27
    26
    Units: log10 copies per mL
    arithmetic mean (standard error)
        Day 6: 0 hour (n=27, 26)
    0.821 ( 0.349 )
    2.898 ( 0.630 )
        Day 6: 12 hour (n=26, 26)
    1.261 ( 0.433 )
    2.939 ( 0.604 )
        Day 7: 0 hour (n=27, 26)
    1.761 ( 0.436 )
    3.072 ( 0.586 )
        Day 7: 12 hour (n=27, 25)
    1.552 ( 0.443 )
    3.025 ( 0.530 )
    No statistical analyses for this end point

    Secondary: VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7

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    End point title
    		 VL-AUC of RSV by Quantitative Culture of RSV (Plaque Assay) on Day 6 and 7
    End point description
    VL-AUC of RSV by the quantitative culture of nasal wash samples was determined. pfu*h/mL stands for plaque-forming units hour per millilitre. The ITTc population is a subset of the FAS (all subjects who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) including all randomized, vaccinated and challenged subjects. Here 'n' (number analyzed) signifies the number of subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Day 6 (0 hour and 12 hours) and Day 7 (0 hour and 12 hours)
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    27
    26
    Units: log10 pfu*h/mL
    arithmetic mean (standard error)
        Day 6: 0 hour (n=27, 26)
    0.278 ( 0.1936 )
    1.587 ( 0.4159 )
        Day 6: 12 hour (n=27, 26)
    0.304 ( 0.2198 )
    1.737 ( 0.4320 )
        Day 7: 0 hour (n=27, 26)
    0.101 ( 0.1015 )
    1.226 ( 0.3505 )
        Day 7: 12 hour (n=27, 25)
    0.276 ( 0.1931 )
    1.237 ( 0.3891 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Symptomatic RSV Infections

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    End point title
    		 Percentage of Subjects with Symptomatic RSV Infections
    End point description
    Symptomatic RSV infection is defined in two ways (Conservative and Liberal). Conservative: subjects had 2 or more quantifiable RT-PCR measurements on different samples, with one of following: symptoms of 2 different categories of subject symptom card (SSC) (Upper Respiratory [runny/stuffy nose, sneezing, sore throat, earache], Lower Respiratory [cough, shortness of breath, chest tightness, wheeze], Systemic [malaise, headache, muscle and/or joint ache]) regardless of grade and assessment timepoint or Grade 2 symptom from any category; Liberal (RT-PCR): had 2/more quantifiable RT-PCR measurements, with clinical symptom of any severity. The Intent-to-treat-Challenge (ITTc) population is a subset of the Full Analysis Set (FAS) (all subjects who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) included all randomized, vaccinated and challenged subjects.
    End point type
    Secondary
    End point timeframe
    From Day 2 to Day 12
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    27
    26
    Units: Percentage of subjects
    number (not applicable)
        Liberal
    33.3
    61.5
        Conservative
    22.2
    46.2
    No statistical analyses for this end point

    Secondary: Total Clinical Symptoms Score at Day 6 and 7

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    End point title
    		 Total Clinical Symptoms Score at Day 6 and 7
    End point description
    The total clinical symptom score was determined as the sum of the scores (grades) ranges from 0 (no symptom) to 52 (severe symptoms) of the 13 self-reportable symptoms on the SSC. Clinical symptoms includes runny nose, stuffy nose, sneezing, sore throat, ear ache, malaise, headache, muscle and/or joint ache, chilliness/ feverishness, cough, chest tightness, shortness of breath and wheeze. For every separate symptom, the score ranges from 0 (I have no symptom) to 4 (its quite bothersome most of the times and stop from participating in activities). The ITTc population is a subset of the FAS (all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations) including all randomized, vaccinated and challenged subjects.
    End point type
    Secondary
    End point timeframe
    Day 6 and 7: morning, afternoon and evening
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    27
    26
    Units: Units on a scale
    arithmetic mean (standard error)
        Day 6: Evening
    0.5 ( 0.28 )
    2.5 ( 0.65 )
        Day 6: Morning
    0.6 ( 0.18 )
    2.6 ( 0.64 )
        Day 6: Afternoon
    0.4 ( 0.18 )
    2.8 ( 0.74 )
        Day 7: Evening
    0.6 ( 0.32 )
    2.5 ( 0.63 )
        Day 7: Morning
    0.6 ( 0.23 )
    2.5 ( 0.70 )
        Day 7: Afternoon
    0.6 ( 0.32 )
    2.5 ( 0.70 )
    No statistical analyses for this end point

    Secondary: Weight of Mucus Secretions Over Time

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    End point title
    		 Weight of Mucus Secretions Over Time
    End point description
    The weight mucous over time was determined in grams using eCRF forms. Subjects were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the subjects should store them in an airtight plastic bag to calculate the weight of mucus from Day 0 to Day 12. All paper tissues used by each subjects were collected for each 24-hour period up to Day 12, to determine daily mucus weight. The ITTc population is a subset of the FAS (all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations) including all randomized, vaccinated and challenged subjects. Here 'n' (number analyzed) signifies the number of subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    27
    26
    Units: Grams
    arithmetic mean (standard error)
        Day 0 (27, 25)
    0.586 ( 0.1883 )
    0.175 ( 0.0913 )
        Day 1 (26, 25)
    0.228 ( 0.0621 )
    0.086 ( 0.0333 )
        Day 2 (27, 25)
    0.997 ( 0.2350 )
    0.428 ( 0.1459 )
        Day 3 (27, 25)
    0.970 ( 0.2176 )
    0.543 ( 0.1333 )
        Day 4 (27, 26)
    1.164 ( 0.3535 )
    0.714 ( 0.2123 )
        Day 5 (27, 26)
    1.440 ( 0.8609 )
    1.068 ( 0.3539 )
        Day 6 (27, 26)
    1.226 ( 0.4925 )
    3.132 ( 1.0991 )
        Day 7 (27, 26)
    1.715 ( 0.7201 )
    5.124 ( 1.3257 )
        Day 8 (27, 26)
    0.799 ( 0.2960 )
    3.230 ( 1.1022 )
        Day 9 (27, 26)
    1.004 ( 0.4147 )
    1.798 ( 0.4406 )
        Day 10 (27, 26)
    0.907 ( 0.3457 )
    1.785 ( 0.4838 )
        Day 11 (27, 26)
    0.749 ( 0.2430 )
    1.172 ( 0.3442 )
        Day 12 (27, 26)
    0.622 ( 0.2647 )
    0.990 ( 0.3005 )
    No statistical analyses for this end point

    Secondary: Number of Tissue Count Over Time

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    End point title
    		 Number of Tissue Count Over Time
    End point description
    Number of tissues used by subjects per time point were reported using eCRF forms. Subjects were given pre-weighed packets of paper tissues. After each tissue was used for nose blowing or sneezing, the subjects should store them in an airtight plastic bag to calculate the number of tissues used from Day 0 to Day 12. All paper tissues used by each subjects were collected for each 24-hour period up to Day 12, to determine daily number of tissues used. The ITTc population is a subset of the FAS (all subjects who were randomized and received study vaccine, regardless of the occurrence of protocol deviations) including all randomized, vaccinated and challenged subjects.
    End point type
    Secondary
    End point timeframe
    Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    27
    26
    Units: Tissues
    arithmetic mean (standard error)
        Day 0
    1.8 ( 0.53 )
    0.7 ( 0.33 )
        Day 1
    1.7 ( 0.41 )
    0.7 ( 0.27 )
        Day 2
    2.9 ( 0.65 )
    1.2 ( 0.32 )
        Day 3
    1.9 ( 0.45 )
    1.3 ( 0.28 )
        Day 4
    2.3 ( 0.49 )
    1.5 ( 0.31 )
        Day 5
    2.1 ( 0.81 )
    2.3 ( 0.68 )
        Day 6
    2.4 ( 0.77 )
    5.1 ( 1.59 )
        Day 7
    2.8 ( 0.92 )
    8.1 ( 1.94 )
        Day 8
    2.0 ( 0.71 )
    5.2 ( 1.38 )
        Day 9
    2.3 ( 0.72 )
    2.8 ( 0.53 )
        Day 10
    1.8 ( 0.61 )
    2.7 ( 0.61 )
        Day 11
    1.6 ( 0.47 )
    2.0 ( 0.50 )
        Day 12
    1.4 ( 0.40 )
    1.7 ( 0.45 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Unsolicited Adverse Events (AEs)

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    End point title
    		 Percentage of Subjects With Unsolicited Adverse Events (AEs)
    End point description
    Unsolicited AEs are all AEs for which subjects were specifically not questioned in the subject diary. An AE is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. The Full Analysis Set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) included all evaluable subjects who were analyzed at specified categories.
    End point type
    Secondary
    End point timeframe
    Up to 28 days post-vaccination and up to 28 days post-challenge
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    31
    32
    Units: Percentage of subjects
    number (not applicable)
        Post-dose (n=31, 32)
    35.5
    46.9
        Post-challenge (n=27,26)
    74.1
    69.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Subjects With Serious Adverse Events (SAEs)
    End point description
    An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. The Full Analysis Set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) included all evaluable subjects who were analyzed at specified categories.
    End point type
    Secondary
    End point timeframe
    Up to 6 months post-vaccination and up to 6 months post-challenge
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    31
    32
    Units: Percentage of subjects
    number (not applicable)
        Post-vaccination (n=31, 32)
    0
    0
        Post-challenge (n=27, 26)
    3.2
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Solicited Local and Systemic AEs

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    End point title
    		 Percentage of Subjects With Solicited Local and Systemic AEs
    End point description
    Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. The Full Analysis Set included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Secondary
    End point timeframe
    7 days post-vaccination (Day -21)
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    31
    32
    Units: Percentage of Subjects
    number (not applicable)
        Solicited local AEs
    100.0
    18.8
        Solicited systemic AEs
    100.0
    50.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Vital Signs Abnormalities

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    End point title
    		 Percentage of Subjects With Vital Signs Abnormalities
    End point description
    Percentage of subjects with vital signs abnormalities were reported. Vital signs measurements included body temperature (measured in degree celsius from less than [<] 37.5 to <39.5), respiratory rate, systolic and diastolic blood pressure, and pulse rate, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). The Full Analysis Set included all subjects who were randomized and received study vaccine, regardless of the occurrence of protocol deviations. Here 'n' (number analyzed) included all evaluable subjects who were analyzed at specified categories.
    End point type
    Secondary
    End point timeframe
    Up to Day 28 post-challenge
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    31
    32
    Units: Percentage of subjects
    number (not applicable)
        Post-dose: Temperature (<37.5)
    64.5
    93.8
        Post-dose: Temperature (37.5-<38.0)
    22.6
    3.1
        Post-dose: Temperature (38.0-<38.5)
    6.5
    0
        Post-dose: Temperature (38.5-<39.0)
    6.5
    3.1
        Post-dose: Bradycardia (pulse): Grade 1
    12.9
    3.1
        Post-dose: Bradycardia (pulse): Grade 2
    6.5
    6.3
        Post-dose: Bradycardia (pulse): Grade 3/4
    3.2
    0
        Post-dose: Hypertension (diastolic): Grade 1
    0
    3.1
        Post-dose: Hypertension (diastolic): Grade 2
    6.5
    0
        Post-dose: Hypertension (systolic): Grade 1
    3.2
    3.1
        Post-dose: Respiratory rate: Grade 1
    25.8
    18.8
        Post-dose: Tachycardia (pulse): Grade 1
    3.2
    0
        Post-challenge: Bradycardia (pulse): Grade 1
    18.5
    11.5
        Post-challenge: Bradycardia (pulse): Grade 2
    3.7
    3.8
        Post-challenge: Bradycardia (pulse): Grade 3/4
    3.7
    0
        Post-challenge: Hypertension (diastolic): Grade 1
    3.7
    0
        Post-challenge: Hypertension (systolic): Grade 1
    0
    7.7
        Post-challenge: Respiratory rate: Grade 1
    25.9
    26.9
        Post-challenge: Tachycardia (pulse): Grade 1
    3.7
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Electrocardiogram (ECG) Abnormalities

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    End point title
    		 Percentage of Subjects With Electrocardiogram (ECG) Abnormalities
    End point description
    ECG parameters included heart rate, PR, QRS, QTcB, QTcF, and the uncorrected QT interval which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). The ITTc population is a subset of the FA (all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations) set including all randomized, vaccinated and challenged subjects.
    End point type
    Secondary
    End point timeframe
    Up to Day 12 post challenge
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    27
    26
    Units: Percentage of Subjects
    number (not applicable)
        Heart rate: Abnormally low: Grade 1
    0
    3.8
        Heart rate: Abnormally low: Grade 2
    0
    3.8
        QTc Bazett (450 millisecond [ms], 480 ms)
    0
    3.8
        QTc Bazett (increase from baseline [30; 60] ms)
    7.4
    11.5
        QTc Fridericia:(increase from baseline[30; 60]ms)
    3.7
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Clinical Laboratory Abnormalities (Graded)

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    End point title
    		 Percentage of Subjects With Clinical Laboratory Abnormalities (Graded)
    End point description
    Percentage of subjects with clinical laboratory abnormalities were reported. The biochemical and hematological parameters analyzed were- Alanine aminotransferase (AA), Alkaline phosphatase (AP), Aspartate aminotransferase (AsP), Hyperkalemia, Hypernatremia, Hypoglycemia, Hypophosphatemia, Hemoglobin, Neutrophils, White blood cell (WBC) – increase and Urine protein, which were graded by FDA Toxicity Grading Scale Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening). The Full Analysis Set (FAS) included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    End point type
    Secondary
    End point timeframe
    Up to Day 28 post-challenge
    End point values
    		 Ad26.RSV.preF (1*10^11 vp) Placebo
    Number of subjects analysed
    31
    32
    Units: Percentage of subjects
    number (not applicable)
        Post Dose: AA: Grade 1 (n=31, 32)
    9.7
    0
        Post Dose: AP: Grade 1 (n=31, 32)
    0
    3.1
        Post Dose: AsA: Grade 1 (n=31, 32)
    6.5
    0
        Post Dose: AsA: Grade 2 (n=31, 32)
    0
    3.1
        Post Dose: Hyperkalemia: Grade 2 (n=31, 32)
    3.2
    0
        Post Dose: Hypernatremia: Grade 2 (n=31, 32)
    3.2
    0
        Post Dose: Hypoglycemia: Grade 2 (n=31, 32)
    0
    3.1
        Post Dose: Hypophosphatemia:Grade 1 (n=31, 32)
    3.2
    0
        Post Dose: Hypophosphatemia:Grade 2 (n=31, 32)
    9.7
    0
        Post Dose: Hemoglobin: Grade 1 (n=31, 32)
    3.2
    3.1
        Post Dose: Hemoglobin: Grade 2 (n=31, 32)
    3.2
    0
        Post Dose: Neutrophils: Grade 1 (n=31, 32)
    12.9
    6.3
        Post Dose: WBC increase: Grade 1 (n=31, 32)
    0
    3.1
        Post Dose: Urine Protein: Grade 1 (n=31, 32)
    3.2
    3.1
        Post Challenge: AA: Grade 1 (n=27, 26)
    25.9
    15.4
        Post Challenge: AA: Grade 2 (n=27, 26)
    7.4
    3.8
        Post Challenge: AP: Grade 1 (n=27, 26)
    0
    3.8
        Post Challenge: AsA: Grade 1 (n=27, 26)
    14.8
    15.4
        Post Challenge: AsA: Grade 2 (n=27, 26)
    3.7
    3.8
        Post Challenge: AsA: Grade 4 (n=27, 26)
    0
    3.8
        Post Challenge: Bilirubin: Grade 2 (n=27, 26)
    3.7
    0
        Post Challenge: Hyperglycemia: Grade 1 (n=27, 26)
    0
    3.8
        Post Challenge: Hyperkalemia: Grade 1 (n=27, 26)
    3.7
    3.8
        Post Challenge: Hypernatremia: Grade 2 (n=27, 26)
    3.7
    0
        Post Challenge: Hypophosphatemia:Grade 1 (n=27,26)
    3.7
    0
        Post Challenge: Hypoproteinemia:Grade 1 (n=27, 26)
    11.1
    0
        Post Challenge: Eosinophils: Grade 1 (n=27, 26)
    0
    7.7
        Post Challenge: Hemoglobin: Grade 1 (n=27, 26)
    7.4
    0
        Post Challenge: Neutrophils: Grade 1 (n=27, 26)
    7.4
    0
        Post Challenge: Platelets: Grade 1 (n=27, 26)
    3.7
    3.8
        Post Challenge: Platelets: Grade 2 (n=27, 26)
    0
    3.8
        Post Challenge: WBC increase: Grade 1 (n=27, 26)
    3.7
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 6 months post-vaccination and up to 6 months post-challenge
    Adverse event reporting additional description
    The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Post-dose: Ad26.RSV.preF (1x10^11 vp)
    Reporting group description
    		 Subjects received a single intramuscular injection of 1*10^11 viral particles (vp) of Ad26.RSV.preF on Day -28.

    Reporting group title
    Post-dose: Placebo
    Reporting group description
    		 Subjects received a single intramuscular injection of matching placebo on Day -28.

    Reporting group title
    Post-challenge: Challenge After Ad26.RSV.preF
    Reporting group description
    		 Subjects undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of 1x1011 vp of Ad26.RSV.preF on Day -28.

    Reporting group title
    Post-challenge: Challenge After Placebo
    Reporting group description
    		 Subjects undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of placebo on Day -28.

    Serious adverse events
    		 Post-dose: Ad26.RSV.preF (1x10^11 vp) Post-dose: Placebo Post-challenge: Challenge After Ad26.RSV.preF Post-challenge: Challenge After Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Reproductive system and breast disorders
    Ovarian Cyst
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Post-dose: Ad26.RSV.preF (1x10^11 vp) Post-dose: Placebo Post-challenge: Challenge After Ad26.RSV.preF Post-challenge: Challenge After Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 31 (12.90%)
    9 / 32 (28.13%)
    16 / 27 (59.26%)
    16 / 26 (61.54%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 32 (0.00%)
    7 / 27 (25.93%)
    3 / 26 (11.54%)
         occurrences all number
    2
    0
    7
    3
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 32 (3.13%)
    2 / 27 (7.41%)
    2 / 26 (7.69%)
         occurrences all number
    2
    1
    2
    2
    Troponin T Increased
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 27 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    0
    2
    Injury, poisoning and procedural complications
    Sunburn
         subjects affected / exposed
    0 / 31 (0.00%)
    2 / 32 (6.25%)
    0 / 27 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 31 (3.23%)
    4 / 32 (12.50%)
    2 / 27 (7.41%)
    2 / 26 (7.69%)
         occurrences all number
    1
    4
    2
    2
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    6 / 27 (22.22%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    6
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 27 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    1 / 27 (3.70%)
    4 / 26 (15.38%)
         occurrences all number
    0
    0
    1
    4
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 32 (3.13%)
    0 / 27 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    1
    1
    0
    2
    Epistaxis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    0 / 27 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    0
    0
    0
    3
    Skin and subcutaneous tissue disorders
    Dry Skin
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 32 (3.13%)
    3 / 27 (11.11%)
    2 / 26 (7.69%)
         occurrences all number
    1
    1
    3
    2
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)
    3 / 27 (11.11%)
    4 / 26 (15.38%)
         occurrences all number
    0
    0
    3
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jul 2018
    Issued to update the secondary endpoints. The power calculations for the present study were based on the AUC results observed in the placebo group in a historical RSV study (53718678RSV2001). The RT-PCR assay, used to measure VL-AUC for the primary endpoint in study 53718678RSV2001, was a different assay than the assay used in the current study. Due to the explorative nature of the present study, the statistical assumptions were monitored by an unblinded monitor throughout the study. It was shown that the assay used in the historical study gave more granularity in the lower range compared to the assay used in the current study. As peak viral load should be less sensitive to the difference in the assays compared to the AUC, this parameter was added as a secondary endpoint. The study objectives and efficacy analysis section were updated accordingly.

    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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