Evidence map›Paper›PMID 34711598›Full record

ArticleBMJ open2021

BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial).

Laure F Pittet, Nicole L Messina, Kaya Gardiner, Francesca Orsini, Veronica Abruzzo, Samantha Bannister, Marc Bonten, John L Campbell, Julio Croda, Margareth Dalcolmo and 27 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04327206 (BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers), which is not on this map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
2.9field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04327206 phase3completednot on this map

BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (BRACE) Trial

TypeinterventionalSponsorMurdoch Childrens Research InstituteRan2020 to 2022Enrolled6,828ConditionsCoronavirus Disease 2019 (COVID-19), Respiratory Illness, Corona Virus Infection, COVID-19ArmsBCG Vaccine, 0.9%NaCl
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 41 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

37 authors at 13 institutions in 7 countries.

Laure F PittetInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0002-2395-4574
Nicole L MessinaInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0001-8404-4462
Kaya GardinerInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0001-9796-4567
Francesca OrsiniClinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Veronica AbruzzoInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Samantha BannisterInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0001-7507-3704
Marc BontenUniversity Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands.
John L CampbellUniversity of Exeter Medical School, Exeter, UK.ORCID 0000-0002-6752-3493
Julio CrodaOswaldo Cruz Foundation, Campo Grande, Mato Grosso do Sul, Brazil.ORCID 0000-0002-6665-6825
Margareth DalcolmoHelio Fraga Reference Center, Oswaldo Cruz Foundation Ministry of Health, Rio de Janeiro, Brazil.ORCID 0000-0002-6820-1082
Sonja EliaInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0002-6368-189X
Susie GermanoInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0001-9924-7545
Casey GoodallInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Amanda GweeInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0003-4016-8986
Tenaya JamiesonInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Bruno JardimInstitute of Clinical Research Carlos Borborema, Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Amazonas, Brazil.ORCID 0000-0003-3465-7556
Tobias R KollmannWesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.ORCID 0000-0003-2403-9762
Marcus Vinícius Guimarães LacerdaInstitute of Clinical Research Carlos Borborema, Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Amazonas, Brazil.ORCID 0000-0003-3374-9985
Katherine J LeeDepartment of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.ORCID 0000-0002-8334-0291
Donna LeggeDepartment of Pharmacy, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
Michaela LucasDepartment of Immunology, QE2 Medical Centre, PathWest Laboratory Medicine Western Australia, Nedlands, Western Australia, Australia.ORCID 0000-0001-8881-9990
David J LynnPrecision Medicine Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.ORCID 0000-0003-4664-1404
Ellie McDonaldInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0003-2295-4641
Laurens ManningWesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.ORCID 0000-0003-4334-5351
Craig F MunnsDepartment of Endocrinology & Diabetes, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.ORCID 0000-0001-5898-5808
Kirsten P PerrettDepartment of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.ORCID 0000-0002-5683-996X
Cristina Prat AymerichUniversity Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands.ORCID 0000-0001-6974-9165
Peter RichmondWesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.ORCID 0000-0001-7562-7228
Frank ShannInfectious Diseases, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.ORCID 0000-0002-9899-1804
Eva SudburyInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Paola VillanuevaInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.ORCID 0000-0002-6504-2979
Nicholas J WoodFaculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Katherine LieschkeMelbourne Children's Trial Centre, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Kanta SubbaraoWHO Collaborating Centre for Reference and Research on Influenza and Department of Microbiology and Immunology, University of Melbourne, The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.ORCID 0000-0003-1713-3056
Andrew DavidsonMelbourne Children's Trial Centre, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Nigel CurtisInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia nigel.curtis@rch.org.au.ORCID 0000-0003-3446-4594
BRACE trial Consortium Group
Murdoch Children's Research Institute · AURoyal Children's Hospital · AUThe University of Melbourne · AUThe Kids Research Institute Australia · AUFundação de Medicina Tropical · BRThe University of Sydney · AUFidal · FRFlinders University · AUThe University of Western Australia · AUUniversidade Federal de Mato Grosso do Sul · BRUniversitat Autònoma de Barcelona · ESUniversity Medical Center Utrecht · NLUniversity of Exeter · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBCG vaccination modulates immune responses to unrelated pathogens. This off-target effect could reduce the impact of emerging pathogens. As a readily available, inexpensive intervention that has a well-established safety profile, BCG is a good candidate for protecting healthcare workers (HCWs) and other vulnerable groups against COVID-19. METHODS AND ANALYSIS: This international multicentre phase III randomised controlled trial aims to determine if BCG vaccination reduces the incidence of symptomatic and severe COVID-19 at 6 months (co-primary outcomes) compared with no BCG vaccination. We plan to randomise 10 078 HCWs from Australia, The Netherlands, Spain, the UK and Brazil in a 1:1 ratio to BCG vaccination or no BCG (control group). The participants will be followed for 1 year with questionnaires and collection of blood samples. For any episode of illness, clinical details will be collected daily, and the participant will be tested for SARS-CoV-2 infection. The secondary objectives are to determine if BCG vaccination reduces the rate, incidence, and severity of any febrile or respiratory illness (including SARS-CoV-2), as well as work absenteeism. The safety of BCG vaccination in HCWs will also be evaluated. Immunological analyses will assess changes in the immune system following vaccination, and identify factors associated with susceptibility to or protection against SARS-CoV-2 and other infections. ETHICS AND DISSEMINATION: Ethical and governance approval will be obtained from participating sites. Results will be published in peer-reviewed open-access journals. The final cleaned and locked database will be deposited in a data sharing repository archiving system.

trial registrationClinicalTrials.gov NCT04327206.

Indexed as

BCG VaccineCOVID-19Health PersonnelHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicSARS-CoV-2Treatment OutcomeVaccinationBCG VaccineCOVID-19immunologyinfectious diseasesmicrobiologyvirology

Identifiers

PMID34711598
PMCPMC8557250
OpenAlexW3210249234

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.