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    Summary
    EudraCT Number:2017-004610-26
    Sponsor's Protocol Code Number:OVG2017/10
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-10-25
    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 number2017-004610-26
    A.3Full title of the trial
    Evaluating the Long Term Immunogenicity of adenoviral and MVA vectored Ebola vaccine schedules and response to late boosting with AD26.ZEBOV vaccine: an open-label clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation the duration of the immune response of a late booster dose of a vaccine against Ebola virus disease - AD26.ZEBOV - in healthy adults previously immunised with investigational Ebola vaccine schedules.
    A.3.2Name or abbreviated title of the trial where available
    Re-evaluating Optimal Vaccine Schedules Against Ebola (REVOLVE)
    A.4.1Sponsor's protocol code numberOVG2017/10
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN10481319
    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 SponsorClinical Trials and Research Governance (CTRG), University of Oxford
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportINNOVATE UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportJanssen UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointMatthew Snape
    B.5.3 Address:
    B.5.3.1Street AddressOxford Vaccine Group, CCVTM, Churchill Hospital, Old Road
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 7LE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865611400
    B.5.5Fax number01865289695
    B.5.6E-mailmatthew.snape@paediatrics.ox.ac.uk
    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-ZEBOV
    D.3.4Pharmaceutical form Suspension 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-ZEBOV
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 x 10^10 vp
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ebola Virus Disease
    E.1.1.1Medical condition in easily understood language
    Ebola virus disease (EVD), is a severe, often fatal disease in humans, spread by contact with body fluids.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014071
    E.1.2Term Ebola disease
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term persistence of immunity (both cellular immunity and antibody levels) in healthy volunteers who were vaccinated approximately 2-5 years previously with investigational Ebola vaccines (ChAd3-EBO Z, MVA–BN-FILO, MVA-EBO-Z and Ad26.ZEBOV), and to assess the response to a booster dose of an investigational Ebola vaccine (Ad26.ZEBOV) given approximately 2-5 years after the initial vaccines.
    E.2.2Secondary objectives of the trial
    To assess the safety and reactogenicity of a booster dose of an investigational Ebola vaccine (Ad26.ZEBOV).

    Vaccine safety refers to the tendency of a vaccine to produce adverse health effects in vaccinated individuals while reactogenicity refers to the extent to which the vaccine causes common expected reactions such as mild pain or swelling at the injection site, tiredness and elevated temperature for a short time period after vaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participants must have completed an immunisation schedule in one of the following studies led by the Oxford Vaccine Centre; EBL01 (REC14/SC/1256), EBL04 (REC 15/SC/0108) or EBL05 (REC 15/SC/0267)
    • Willing and able to give written informed consent for participation in the study
    • In good health as determined by medical history, physical examination and clinical judgment of the investigators
    • Females of childbearing potential: willing to use effective contraception (the oral contraceptive pill, contraceptive implant, contraceptive injection, intrauterine device, intrauterine hormone-releasing systems (IUS) barrier methods, vasectomized partner or abstinence) from one month prior to three months after the vaccine. Vaccination will be delayed in female participants who have not used effective contraception for one month prior to Visit 1*
    • Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards*
    • Willing to allow his or her General Practitioner to be notified of participation in the study
    • Agree to be registered on the Trial Over-Volunteering Prevention Service (TOPS) and agree to provide their National Insurance number or passport number (if not a British citizen) for the purposes of registration*
    • Agree to provide National Insurance number and Bank details for reimbursement purposes

    * Participants intending to receive booster dose only
    E.4Principal exclusion criteria
    • History of malignancy
    • Pregnancy or breast feeding
    • New significant medical or surgical history since completion of the previous study (based on participant recall)
    • Receipt or planned receipt of adeno virus based vaccine since the parent Ebola vaccine studies
    • Chronic or recurrent use of medication which modify host immune response
    • Any contraindication to venepuncture, as determined by clinical judgement
    • History of allergy or anaphylaxis to a vaccine or any component within the vaccines used in this study (booster group only)
    • Have any known or suspected impairment or alteration of immune function, resulting from, for example:
    o Congenital or acquired immunodeficiency
    o Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
    o Autoimmune disease
    o Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy (10mg daily or higher) or any systemic corticosteroid (or equivalent) treatment within 14 days prior to vaccination, or for more than 7 days consecutively within the previous 3 months.
    E.5 End points
    E.5.1Primary end point(s)
    The persistence of humoral and cellular immunity against Ebola virus glycoprotein with or without a booster dose of AD26.ZEBOV administered 2 to 5 years after heterologous prime/boost schedules of adenoviral and MVA vectored Ebola vaccine schedules.

    Outcome measures:
    - Humoral: Ebola GP specific IgG as measured by ELISA 12 months from first visit
    - Cellular: Ebola GP specific T cell cytokine response measured using ex vivo interferon-y enzyme-linked immunosorbent spot (ELISPOT) 12 months from first visit
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months from first visit
    E.5.2Secondary end point(s)
    1. Humoral and cellular immunity against Ebola virus glycoprotein before and after a late booster dose of AD26.ZEBOV administered 2 to 5 years after adenoviral and MVA vectored Ebola vaccine schedules.

    2. Humoral and cellular immunity against Ebola virus glycoprotein 2 to 6 years after adenoviral and MVA vectored Ebola vaccine schedules in the absence of a late booster dose.

    3. Safety and reactogenicity of late booster dose of AD26.ZEBOV administered 2 to 5 years after adenoviral and MVA vectored Ebola vaccine schedules.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. and 2. Baseline (Visit 1), 7 days and 1 month post immunisation (baseline and 12 months only for those participants opting not to receive a booster vaccine in this study).

    3. Days 0-3 post immunisation, Days 0-28 post immunisation and Days 0-365.
    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 No
    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
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 months3
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 156
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state156
    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)
    This is not relevant as the intervention is a single dose of vaccine.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-25
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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