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    The EU Clinical Trials Register currently displays   43886   clinical trials with a EudraCT protocol, of which   7296   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-002503-19
    Sponsor's Protocol Code Number:62586
    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:2020-07-30
    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 number2020-002503-19
    A.3Full title of the trial
    BCG vaccination to Reduce the impact of COVID-19 in healthcare workers following Coronavirus Exposure (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 following contact of Coronavirus
    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 SponsorMurdoch Children’s Research Institute (MCRI)
    B.1.3.4CountryAustralia
    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 organisationUniversity of Exeter
    B.5.2Functional name of contact pointExeter University CTU
    B.5.3 Address:
    B.5.3.1Street AddressUniversity of Exeter Medical School
    B.5.3.2Town/ citySt Luke's Campus
    B.5.3.3Post codeEX12LU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01392725229
    B.5.6E-mailS.Rhodes@exeter.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 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.3.1Product nameBCG Vaccin SSI (Netherlands Vaccin Statens Serum Institute) Danish strain 1331
    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 of COVID-19 disease (with 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 of 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 the 12 months
    6. To determine if BCG vaccination compared with placebo reduces the severity of COVID-19 disease measured over the 12 months
    7. To determine if BCG vaccination compared with placebo reduces the rate and severity of illness measured over the 12 months

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

    9. To determine if BCG vaccination compared with placebo reduces hospital-related health costs in healthcare workers.

    10. To evaluate the safety of BCG vaccination in adult healthcare workers.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The trial includes a pre-planned meta-analysis with data from the 2834 participants recruited in first phase of this study (in Australia only) which followed the same protocol but where participants were randomised between BCG and no BCG at the time of receiving a flu vaccination, with a total sample size of 10078. UK participants will not be part of this analysis.
    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
    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
    5 Already part of this trial, recruited at a different hospital.
    6 Participation in another COVID-19 prevention trial
    E.5 End points
    E.5.1Primary end point(s)

    1.Number of participants with COVID-19 disease defined as fever or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire), plus a positive SARS-Cov-2 test (PCR or serology) over the 6 months following randomisation.

    2.Number of participants with COVID-19 positive test plus
    1. Dead (as a consequence of COVID-19 disease)
    OR
    2. Hospitalised (including mechanical ventilation and death)
    OR
    3. Non-hospitalised severe disease, defined as
    Non-ambulant1 for ≥ 3 consecutive days OR Unable to work2 for ≥ 3 consecutive days

    1 “pretty much confined to bed (meaning finding it very difficult to do any normal daily activities”
    2 “I do not feel physically well enough to go to work”
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    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 days29
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days29
    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: 7244
    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 state1000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4000
    F.4.2.2In the whole clinical trial 7244
    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- participant’s care will stay with NHS usual care
    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 Decision2020-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-11
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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