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    Summary
    EudraCT Number:2020-002503-19
    Sponsor's Protocol Code Number:62586
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-06-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-002503-19
    A.3Full title of the trial
    BCG vaccination to Reduce the impact of COVID-19 in healthcare workers (BRACE) Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tuberculosis vaccination to Reduce the impact of Coronavirus infection in healthcare workers
    A.3.2Name or abbreviated title of the trial where available
    BRACE
    A.4.1Sponsor's protocol code number62586
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04327206
    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 SponsorUMC Utrecht
    B.1.3.4CountryNetherlands
    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 supportBill and Melissa Gates Foundation
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportMCRI
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMC Utrecht
    B.5.2Functional name of contact pointsponsor-Europe
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3188755 0350
    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 BCG Vaccin SSI (Netherlands Vaccin Statens Serum Institute) Danish strain 1331
    D.2.1.1.2Name of the Marketing Authorisation holderAJ VACCINES A/S
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate and solvent for solution for injection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SARS-CoV-2 infection
    E.1.1.1Medical condition in easily understood language
    The intervention has a protective objective which is to improve the clinical course of coronavirus infection in Health Care Workers. Health Care Workers are, in general, healthy.
    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 HLT
    E.1.2Classification code 10047490
    E.1.2Term Virus identification and serology
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To determine if BCG vaccination (Intervention) compared with placebo (Comparator) reduces the incidence of COVID-19 disease (Outcome) measured over the 6 months following randomisation (Time) in healthcare workers exposed to SARS-CoV-2 (Participants).
    2. To determine if BCG vaccination (Intervention) compared with placebo (Comparator) reduces the incidence of severe COVID-19 disease (with COVID 19 related death, hospitalisation, or non-hospitalised severe disease (defined as Non-ambulant1 for ≥ 3 consecutive days OR Unable to work2 for ≥ 3 consecutive days) (Outcome) measured over the 6 months following randomisation (Time) in healthcare workers exposed to SARS-CoV-2 (Participants).
    E.2.2Secondary objectives of the trial
    3. To determine if BCG vaccination compared with placebo reduces the incidence of COVID-19 disease measured over the 12 months
    4. To determine if BCG vaccination compared with placebo reduces the incidence of severe COVID-19 disease measured over the 12 months
    5. To determine if BCG vaccination compared with placebo prolongs the time to first SARS-CoV-2-proven respiratory illness measured over 6 and 12 months
    6. To determine if BCG vaccination compared with placebo reduces the severity of COVID-19 disease measured over 6 and 12 months
    7. To determine if BCG vaccination compared with placebo reduces the rate and severity of illness measured over 6 and 12 months

    8. To determine if BCG vaccination compared with placebo reduces absenteeism in healthcare workers

    9. To evaluate the safety of BCG vaccination in adult healthcare workers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Over 18 years of age
    • Healthcare worker
    • Provide a signed and dated informed consent form
    • Pre-randomisation blood collected
    E.4Principal exclusion criteria
    1 Has any BCG vaccine contraindication
    o Fever or generalised skin infection (where feasible, randomisation can be delayed until cleared)
    o Weakened resistance toward infections due to a disease in/of the immune system
    o People with any serious underlying illness (such as malignancy)
    o Known or suspected HIV infection,11 even if they are asymptomatic or have normal immune function.
    o People with active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination
    o Pregnant
    o Another live vaccine administered in the month prior to randomisation
    o Require another live vaccine to be administered within the month following BCG randomisation
    o Known anaphylactic reaction to any of the ingredient present in the BCG vaccine
    o Previous active TB disease
    o Currently receiving long term (more than 1 month) treatment with isoniazid, rifampicin or quinolone as these antibiotics have activity against Mycobacterium bovis
    2 Previous adverse reaction to BCG vaccine (significant local reaction (abscess) or suppurative lymphadenitis)
    3 BCG vaccine given within the last year
    4 Have previously had a SARS-CoV-2 positive test result (positive PCR on a respiratory sample or a positive SARS-CoV-2 diagnostic antigen test approved by the local jurisdiction’s public health policy
    5 Already part of this trial, recruited at a different hospital.
    6 Participation in another COVID-19 prevention trial
    7 Have previously received a COVID-19 specific vaccine
    E.5 End points
    E.5.1Primary end point(s)
    Number of participants with COVID-19 disease
    Number or participants with severe of COVID-19 disease
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    Number of participants with COVID-19 disease
    Number or participants with severe of COVID-19 disease
    Time to first symptom of COVID-19 in a participant
    Number of episodes of COVID-19 disease
    Number of participants with asymptomatic SARS-CoV-2 infection
    Number of days unable to work due to COVID-19 disease
    Number of days confined to bed due to COVID-19 disease
    Number of days with symptoms in any episode of illness for COVID-19 disease
    Number of pneumonia cases (abnormal chest X-ray) associated with a positive SARS-CoV-2 test
    Need for oxygen therapy associated with a positive SARS-CoV-2 test
    Number of admission to critical care and duration of stay associated with a positive SARS-CoV-2 test
    Need of mechanical ventilation and duration and a positive SARS-CoV-2 test
    Duration of hospitalisation due to COVID-19
    Number of deaths associated with a positive SARS-CoV-2 test
    Number of participants with fever or respiratory illnessNumber of episodes of fever or respiratory illness
    Number of days unable to work due to fever or respiratory illness
    Number of days confined to bed due to fever or respiratory illness
    Number of days with symptoms in any episode of illness
    Number of pneumonia cases (abnormal chest X-ray)
    Need for oxygen therapy
    Number of admission to critical care
    Need of mechanical ventilation
    Number of deaths
    Duration of hospitalisation due to fever or respiratory illness
    Number of days of unplanned absenteeism for any reason
    Hospital-related health costs associated with participant hospitalisation
    Type and severity of local and systemic adverse event over the 3 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6, 9 and 12 months
    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 Yes
    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) No
    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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Australia
    Brazil
    Netherlands
    Spain
    United Kingdom
    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
    This trial may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause.
    Circumstances that may warrant termination or suspension include, but are not limited to:
    • Determination of an unexpected, significant, or unacceptable risk to participants that meets the definition of a SSI
    • Insufficient compliance
    • Data that are not sufficiently complete and/or evaluable
    • Demonstration of efficacy
    • Determination that the primary endpoint has been met
    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 months2
    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 months5
    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: 10000
    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 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 state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 10000
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-27
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