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    Summary
    EudraCT Number:2017-003194-33
    Sponsor's Protocol Code Number:VAC18193RSV2002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2017-003194-33
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Exploratory 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
    A.4.1Sponsor's protocol code numberVAC18193RSV2002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Vaccines and Prevention B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Vaccines and Prevention B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research and Development
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 20
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAd26.RSV.preF
    D.3.2Product code JNJ-64400141-AAA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAd26.RSV.preF
    D.3.9.3Other descriptive nameJNJ-64400141-AAA
    D.3.9.4EV Substance CodeSUB187098
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2x10e11
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prophylactic respiratory syncytial virus (RSV) vaccine.
    E.1.1.1Medical condition in easily understood language
    Preventive vaccine against RSV.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess a trend for the prophylactic efficacy of a single dose of 1x10e11 vp of Ad26.RSV.preF administered intramuscularly to adults aged 18-50 years in the RSV challenge model in terms of 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.
    E.2.2Secondary objectives of the trial
    -To assess a trend for prophylactic efficacy of a single dose of Ad26.RSV.preF in the RSV challenge model in terms of reduction of nasal wash viral load as measured by the peak viral load of the RT-PCR compared to placebo.
    - To assess the effect of a single dose of 1x10e11 vp of Ad26.RSV.preF on viral load, as measured by RT-PCR and quantitative culture of RSV, and clinical symptoms on Day 6 and Day 7 post-challenge compared to placebo.
    -To assess a trend for prophylactic efficacy of a single dose of 1x10e11 vp of Ad26.RSV.preF in the RSV challenge model in terms of prevention of symptomatic RSV infection defined as two quantifiable RT-PCR measurements and one or more positive clinical symptoms of any grade from two different categories in the symptom scoring system (Upper Respiratory, Lower Respiratory, Systemic), or one Grade 2 symptom from any category compared to placebo.

    Full list of secondary objectives is available in section 2 of the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject is a man or woman, ≥18 to ≤50 years old on the day of ICF signature.
    2. Subjects must be in good health, without significant medical illness, on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, and the results of clinical laboratory tests performed within 56 days of vaccination. If there are abnormalities, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject’s source documents and initialed by the investigator.
    3. Subjects must have a non-clinically significant 12-lead ECG within 56 days of vaccination including:
    a) normal sinus rhythm (heart rate between 50 and 100 beats per minute [bpm], extremes included)
    b) QT interval corrected for heart rate according to Fridericia (QTcF) interval ≤450 ms
    c) QT interval corrected for heart rate according to Bazett (QTcB) interval ≤450 ms
    d) QRS interval <120 ms
    e) PR interval ≤210 ms.
    Note: Retesting of abnormal ECG values that may lead to exclusion will be allowed once without prior approval from the sponsor. Repeate ECG due to equipment failure will not count as a retest. Subjects with a normal value at retest may be included.
    4. Subjects must be sero-suitable for RSV within 90 days of vaccination (low immunity to the RSV-A Memphis 37b virus using a virus neutralization assay).
    5. Subject must be healthy on the basis of clinical laboratory tests performed within 56 days of vaccinaiton. If the results of the laboratory screening tests are outside the local laboratory normal reference ranges and additionally within the limits of toxicity Grade 1 according to the US Food and Drug Administration (FDA) toxicity tables (ie, for tests in the FDA table ), the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the subject’s source documents and initialed by the investigator.
    Note: If laboratory screening tests are out of local laboratory normal ranges and deemed clinically significant, repeat of screening tests is permitted once using an unscheduled visit during the screening period to assess eligibility.

    Further criteria are defined in section 4.1 of the protocol.
    E.4Principal exclusion criteria
    1. Subject has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments.
    2. Subject has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively or current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection.
    3. Subject has previously participated in, or is currently participating in an RSV vaccine study, has previously received treatment with immunoglobulin or blood products in the 4 months before the planned administration of study vaccine or has any plans to receive such treatment during the study.
    4. Subject has a history of chronic urticaria (recurrent hives), eczema and/or atopic dermatitis or has a history of acute polyneuropathy (eg, Guillain-Barré syndrome).
    5. Subject has abnormal function of the immune system resulting from:
    - clinical conditions (e.g. autoimmune disease or immunodeficiency)
    - chronic (longer than 10 days) or recurrent use of systemic corticosteroids during the study and within 6 months before administration of study vaccine (Note: occular, topical or inhaled steroids are allowed)
    - Administration of antineoplastic and immunomodulating agents or radiotherapy during the study and within 6 months before administration of study vaccine.

    Further criteria are defined in section 4.2 of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the VL-AUC (area under curve for viral load) of RSV-A Memphis 37b as determined by quantitative RT-PCR assay of nasal wash samples.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Nasal wash samples are taken every 12 (±1) hours beginning two days after inoculation of the challenge virus until discharge from the challenge Unit.
    E.5.2Secondary end point(s)
    1. Peak viral load of RSV-A Memphis 37b, defined as the maximum viral load as determined by quantitative RT-PCR assay of nasal wash samples, observed over the entire time period.

    2. Occurrence of symptomatic RSV infection defined as two quantifiable RT-PCR measurements at different time points plus symptoms of any grade from two different categories from the subject symptom card (SSC) or two quantifiable RT-PCR measurements plus any Grade 2 symptom from any category.
    The three SSC categories are:
    - Upper Respiratory symptoms: runny nose, stuffy nose, sneezing, sore throat, earache
    - Lower Respiratory symptoms: cough, shortness of breath, chess tightness, wheeze
    - Systemic symptoms: malaise, headache, muscle and/or joint ache, chilliness/ feverishness

    3. Occurrence of RSV infection defined as two quantifiable RT-PCR measurements plus any clinical symptom of any severity.

    4. Total weight of mucus produced and tissue count.

    5. Safety and tolerability
    - Unsolicited adverse events (AEs) from informed consent form (ICF) signature until 28 days after vaccination, and from the entry into the Unit until 28 days after challenge.
    - Safety data including, but not limited to, physical examinations, vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory results (including biochemistry, hematology, and urinalysis).
    - Serious adverse events (SAEs) throughout the study (from signing the ICF to the end of the study, 6 months after vaccination).
    - Solicited local and systemic AEs for 7 days after vaccination.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Nasal wash samples are taken every 12 (±1) hours beginning two days after inoculation of the challenge virus until discharge from the challenge Unit.

    2. 3 and 4 -samples collected at multiple timepoints until discharge from the challenge unit

    5. - unsolicited AEs from ICF signature until 28 days after vaccination and from entry to the Unit (Day -2 or -1) until 28 days after challenge
    - safety data throughout the study
    - SAEs throughout the study
    - solicited local and systemic AEs for 7 days after vaccination
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None - it is a healthy volunteer trial
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-27
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