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    Summary
    EudraCT Number:2020-001228-32
    Sponsor's Protocol Code Number:COV002
    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:2020-04-21
    Trial 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 number2020-001228-32
    A.3Full title of the trial
    A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigating a Vaccine Against COVID-19
    A.3.2Name or abbreviated title of the trial where available
    Investigating a Vaccine Against COVID-19 (COV002)
    A.4.1Sponsor's protocol code numberCOV002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCTRG
    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 supportUKRI
    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 pointAndrew Pollard
    B.5.3 Address:
    B.5.3.1Street AddressCCVTM, Churchill Hospital
    B.5.3.2Town/ cityHeadington, Oxford
    B.5.3.3Post codeOX37LE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4418655611400
    B.5.6E-mailAndrew.pollard@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 nameChAdOx1 nCoV-19
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Nimenrix
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameNimenrix
    D.3.4Pharmaceutical form Powder and solvent for 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.3.9.4EV Substance CodeAS1
    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) No
    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 No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Menveo
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxosmithkline
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMenveo
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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 No
    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
    SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    The virus is part of the Coronavirus family which may cause respiratory infections ranging from the common cold to more severe diseases. This recently discovered coronavirus causes COVID-19.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older.
    To assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults.
    E.2.2Secondary objectives of the trial
    To assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19
    To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19
    To assess humoral immunogenicity of ChAdOx1 nCoV-19
    To assess cellular immunity of ChAdOx1 nCoV-19 in older adults (groups 1, 2, 7 and 8 only)
    To assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only)
    Exploratory Immunology
    Measure exposure to COVID-19
    To assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection
    Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002
    Compare safety, reactogenicity and immunogenicity between different dosing methods (Abs260, Abs260 corrected for PS80 and qPCR) of ChAdOx1 nCoV-19
    To assess vaccine induced mucosal immunity
    To compare viral shedding on sto
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adults aged 18 years or older (groups 4 and 6); aged 18-55 years (group 5 and 11)
    Adults aged 56-69 years (groups 1,7 and 9)
    Adults aged 70 years and older (groups 2,8 and 10)

    Able and willing (in the Investigator’s opinion) to comply with all study requirements.
    Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures.
    For females of childbearing potential only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination.
    Agreement to refrain from blood donation during the course of the study.
    Provide written informed consent.
    Parent/Guardian provides informed consent

    Additional Inclusion criteria to Group 12 (HIV sub-study):
    HIV positive
    Receiving antiretroviral therapy
    Undetectable HIV viral load
    CD4>350 cells/mL
    E.4Principal exclusion criteria
    • Participation in COVID-19 prophylactic drug trials for the duration of the study.
    Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The COV002 study team should be informed as soon as possible.
    • Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.
    Note: Disclosure of serostatus post enrolment may accidently unblind participants to group allocation. Participation in COV002 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys
    • Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination, with the .exception of the licensed seasonal influenza vaccination and the licenced pneumococcal vaccination. Participants will be encouraged to receive these vaccination at least 7 days before or after their study vaccine.
    • Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). ). This exclusion criteria will not apply to group 11, as recruitment will be targeted at those volunteers who previously received a ChAdOx1 vectored vaccine.
    • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
    • Any confirmed or suspected immunosuppressive or immunodeficient state (except group 12, where HIV infected participants are allowed); asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤14 days)
    • History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY
    • Any history of angioedema.
    • Any history of anaphylaxis.
    • Pregnancy, lactation or willingness/intention to become pregnant during the study.
    • Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
    • History of serious psychiatric condition likely to affect participation in the study.
    • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
    • Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
    • Suspected or known current alcohol or drug dependency.
    • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
    • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
    • History of laboratory confirmed COVID-19 (except groups 5d, 5e, 9, 10 and 11).
    - Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 5e, 9, 10 and 11)
    - NB: volunteers with previous PCR or other NAAT positive result are also allowed in groups 9, 10 and 11

    Additional Exclusion criteria to Groups 4 and 6
    • History of allergic disease or reactions likely to be exacerbated by Paracetamol

    1.1.1 Re-vaccination exclusion criteria (two-dose groups only)
    The following AEs associated with any vaccine, or identified on or before the day of vaccination constitute absolute contraindications to further administration of an IMP to the volunteer in question. If any of these events occur during the study, the subject will be withdrawn from the study and followed up by the clinical team or their GP until resolution or stabilisation of the event:
    • Anaphylactic reaction following administration of vaccine
    • Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    Virologically confirmed (PCR or other NAAT positive result) symptomatic COVID-19 infection
    E.5.1.1Timepoint(s) of evaluation of this end point
    As required
    E.5.2Secondary end point(s)
    To assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19
    To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19
    To assess humoral immunogenicity of ChAdOx1 nCoV-19
    To assess cellular immunity of ChAdOx1 nCoV-19 in older adults and in children (groups 1, 2, 7 and 8 only)
    To assess the safety and immunogenicity of a booster dose of ChAdOx1 nCOV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only)
    To assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection
    Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002
    Compare safety, reactogenicity and immunogenicity between different dosing methods (Abs260, Abs260 corrected for PS80 and qPCR) of ChAdOx1 nCoV-19
    To assess vaccine induced mucosal immunity
    To compare viral shedding on stool samples and/or rectal swabs of SARS-CoV-2 PCR or other NAAT positive individuals
    To compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses (groups 1, 2, 7 and 8)
    To describe the impact of previous vaccination with other ChAdOx1 vectored vaccines in immune responses to ChAdOx1 nCoV-19
    To assess the cell-mediated and humoral immunogenicity profile of ChAdOx1 nCoV-19 vaccine in HIV infected adults
    To assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults
    To assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in HIV infected adults
    To assess Impact of vaccination on HIV reservoirs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety, tolerability and reactogenicity - for 7 days after the vaccination and occurence of unsolicited adverse events for 28 days
    To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 - throughout study
    To assess humoral and cellular immunogenicity of ChAdOx1 nCoV-19 - D0, D7, D14, D28, D42,D56, D182, D364
    To assess the safety and immunogenicity of a booster dose of ChAdOx1 nCOV-19 - for 7 days after the vaccination and occurence of unsolicited adverse events for 28 days and immunogenicity at end of study.
    Efficacy against infection - throughout the study from weekly swabs
    Batch comparison - D0, D7, D14, D28, D56, D182 and D364
    Mucosal immunity: D0 and D28 (subset of participants only)
    Stool viral shedding: at 7 days post PCR or NAAT +ve
    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 No
    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) Yes
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned20
    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 Yes
    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
    The end of the trial is the date of the last assay conducted on the last sample collected
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 60
    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: 11090
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1240
    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 Yes
    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 state12390
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12390
    F.4.2.2In the whole clinical trial 12390
    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)
    Continued provision of the intervention is not appropriate, as the intervention is an investigational vaccine. All participants are healthy volunteers. If this vaccine is proven to be efficacious following analysis of the primary endpoint and if the DSMB agrees, participants allocated to MenACWY group may be offered the IMP, should extra doses become available.
    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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-08
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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