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    Summary
    EudraCT Number:2021-004889-35
    Sponsor's Protocol Code Number:UCDCRC/21/10
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-29
    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 ConcernedIreland - HPRA
    A.2EudraCT number2021-004889-35
    A.3Full title of the trial
    An International Multicentre, Phase 2, Randomised, Adaptive Protocol to determine the safety, optimal timing of and humoral immune response after administering a 3rd homologous mRNA vaccination dose against SARS-CoV-2 in the general population (18+ years) already fully vaccinated against SARS-CoV-2 (EU-COVAT-2 BOOSTAVAC).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a multicentre Phase II trial evaluating different booster strategies in individuals already vaccinated against SARS-CoV-2. This trial allows testing of different booster strategies for comparative assessment of their immune responses and safety against SARS-CoV-2 and its variants. This study tests whether a 3rd vaccination dose is needed and determines the optimal booster vaccination schedule for further evaluation in a phase III trial.
    A.3.2Name or abbreviated title of the trial where available
    EU-COVAT-2 BOOSTAVAC
    A.4.1Sponsor's protocol code numberUCDCRC/21/10
    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 SponsorUniversity College Dublin
    B.1.3.4CountryIreland
    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 supportEU Horizon 2020 research and innovation funding framework
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College Dublin
    B.5.2Functional name of contact pointDepartment of Infectious Diseases
    B.5.3 Address:
    B.5.3.1Street AddressBelfield
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeDublin 4
    B.5.3.4CountryIreland
    B.5.4Telephone number35312215333
    B.5.5Fax number35312214136
    B.5.6E-mailpaddy.mallon@ucd.ie
    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 Yes
    D.2.1.1.1Trade name Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Concentrate for dispersion 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 INNComirnaty
    D.3.9.3Other descriptive nameCOVID-19 mRNA vaccine (nucleoside-modified)
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.45
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Acute Respiratory Syndrome Coronavirus 19 (COVID-19/SARS-CoV-2)
    E.1.1.1Medical condition in easily understood language
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084457
    E.1.2Term COVID-19 immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084462
    E.1.2Term SARS-CoV-2 vaccination
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overarching objective is to evaluate anti-SARS-CoV-2 immune responses to different booster strategies in individuals already fully vaccinated against SARS-CoV-2. Specifically, this subprotocol will determine the need for, optimal timing of and immunogenicity of administering a 3rd homologous vaccination dose against SARS-CoV-2 in the general population (18+ years) who have already vaccinated with two doses of the BNT162b2 vaccine.
    E.2.2Secondary objectives of the trial
    • To determine the change in cellular immune response measured by a direct from blood qPCR based T-cell activation (dq-TACT) assay at 14 days after 3rd dose vaccine in comparison to prior to 3rd dose vaccination.
    • To correlate humoral immune response, cellular immune responses and viral neutralising capacity against wild type SARS-CoV-2
    • To determine the durability of humoral and cellular immune responses after initial and third dose vaccination
    • To determine rates of, and maximum disease severity associated with confirmed SARS-CoV-2 infections occurring after enrolment in study participants before and after 3rd dose vaccine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adults aged 18 years or above at baseline
    -Be no more than 9 months (+/- 6 weeks) from the date of second dose of BNT162b2 vaccine at the time of consent
    -Have received two homologous doses as primary vaccination against SARS CoV-2 with BNT162b2 vaccine (vaccination status should be documented).
    -No contra-indication against any of the vaccine products in the trial.
    -Written informed consent from the subject has been obtained.
    E.4Principal exclusion criteria
    -Unable to provide written, informed consent
    -Participation in any other interventional trials
    -People who have already received a booster vaccination
    -Any significant or uncontrolled disease posing a risk with vaccination as judged by the investigator (including recent, confirmed positive SARS-CoV-2 test within the previous three weeks)
    - Any significant medical condition that in the opinion of the investigator would necessitate booster vaccination against SARS-CoV-2 within the trial timelines
    - Any kind of dependency on the principal investigator or employed by the sponsor or principal investigator
    -Where a subject received primary vaccination not with two doses of the BNT162b2 mRNA vaccine or the primary vaccination was with two different vaccine products as 1st and 2nd vaccination doses (heterologous vaccination scheme)
    -Any contraindication to the vaccines in the trial at the moment of randomization as per the Summary of Medicinal Product Characteristics, SmPC) or the Investigator’s Brochure, if appropriate. A list of contraindications (including prior anaphylaxis to BNT162b2) are listed in Annex A.
    -Use of drugs with significant interaction with the investigational product
    -Subjects who are pregnant
    -Unwillingness to use highly effective contraceptive methods. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly-effective:
    o Oral hormonal contraception
    o Dermal hormonal contraception
    o Vaginal hormonal contraception (NuvaRing®)
    o Contraceptive plaster
    o Long-acting injectable contraceptives
    o Implants that release progesterone (Implanon®)
    o Tubal ligation (female sterilisation)
    o Intrauterine devices that release hormones (hormone spiral)
    o Double barrier methods
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint comprises a composite endpoint of either an increase in anti-RBD antibody titre to ≥500 IU/mL at day 14 post 3rd dose booster vaccine in those with anti-RBD antibody titre of ≤500 IU/mL immediately before 3rd dose booster vaccination or a 2-fold increase in anti-RBD antibody titre at day 14 following 3rd dose vaccination in those with anti-RBD titre of ≥500 IU/mL immediately before 3rd dose booster vaccination, as measured by quantitative immunoassay targeting the anti-RBD antibody.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days after 3rd dose vaccine
    E.5.2Secondary end point(s)
    • The proportion of subjects reporting positive tests (PCR and/or antigen tests) for SARS-CoV-2 at each reporting time point after enrolment
    • The proportion of subjects who receive 3rd dose vaccination at each specific timepoint that achieve a 2-fold increase in RBD antibody titre 14 days after the 3rd dose vaccine
    • The proportion of subjects who receive 3rd dose vaccination at each specific timepoint that achieve an anti-RBD antibody titre ≥500 IU/mL 14 days after the 3rd dose vaccine
    • Rate of 2-fold RBD antibody titre increase following 3rd dose vaccination measured by quantitative immunoassay targeting the spike 1 (S1) and nucleocapsid (NC) antibodies at 14 days after 3rd dose vaccine as compared to immediately before vaccination

    Safety/tolerability:
    • Unsolicited AEs for 14 days after 3rd dose
    • Solicited AEs for 7 days after 3rd dose
    • Spontaneous AEs until the end of trial
    • Rate of serious adverse events (SAEs) Grade ≥3 according to the National Cancer Institute Common Toxicity Criteria until up to three months after 3rd dose

    Laboratory:
    • T-cell activation as measured by a whole blood dq-TACT assay before and 14 days after 3rd dose vaccine
    • Neutralising activity against SARS-CoV-2 wild-type and variants of concern as measured by a standardised viral neutralisation assay (sub-group analysis)

    Exploratory endpoints:
    • Detailed immunophenotyping of immune responses, including metabolomics, proteomics and transcriptomics where relevant (sub-group analysis)
    • Whole genome sequencing of isolated SARS-CoV-2 viral strains detected in breakthrough infections
    • Haemagglutination assay as a surrogate of neutralising capacity
    E.5.2.1Timepoint(s) of evaluation of this end point
    7 and 14 days after 3rd dose vaccine
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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 Yes
    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) 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Control group offered 3rd dose vaccine at the end of the study(19 months after initial vaccination)
    E.8.2.4Number of treatment arms in the trial4
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Denmark
    Germany
    Ireland
    Netherlands
    Norway
    Spain
    Sweden
    Switzerland
    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
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 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 Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 460
    F.4.2.2In the whole clinical trial 500
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation VACCELERATE
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-08
    P. End of Trial
    P.End of Trial StatusOngoing
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