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

LF Pittet; NL Messina; K Gardiner; F Orsini; V Abruzzo; S Bannister; M Bonten; JL Campbell; J Croda; M Dalcolmo; S Elia; S Germano; C Goodall; A Gwee; T Jamieson; B Jardim; TR Kollmann; MVG Lacerda; KJ Lee; D Legge; M Lucas; DJ Lynn; E McDonald; L Manning; CF Munns; KP Perrett; C Prat Aymerich; P Richmond; F Shann; E Sudbury; P Villanueva; NJ Wood; K Lieschke; K Subbarao; A Davidson; N Curtis; C Abreu; L Addlem; S Agius; AAR Barbosa; A Alamrousi; AA da Silva dos Santos; Y Al-Hindawi; SA Da Silveira; LA da Cruz; J Anderson; C Anthony; AAS de Almeida dos Reis Pereira; FA de las Revillas Almajano; A Arnold; B Arrowsmith; K Azzopardi; CB Marti; T Bahaduri; S Barney; L Barrera; A Barriocanal; D Barros; A Bartlett; LBS Muranaka; T Baulman; M Bealing; J Beardsley; ABM Gutierrez; J Bell; V Bennett-Wood; N Bergant; FB Barbosa; W Bijllaardt; P Bimboese; CB de Andrade; K Blauwendraat; W Boersma; PB Garcia; R Bonnici; A Boon; A Bourke; K Bowes; L Brasil; C Brophy; S Buchanan; J Bucholc; A Burns; E Burrell; N Bustos; B Byrne; A Byrne; E Calbo; JC Montes; B Camesella; J Campbell; A Cangas; J Carlin; MC Roque; RCP Diogo; E Carvalho; I Casas; E Castro; R Castro; H Catterick

Journal article

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

LF Pittet, NL Messina, K Gardiner, F Orsini, V Abruzzo, S Bannister, M Bonten, JL Campbell, J Croda, M Dalcolmo, S Elia, S Germano, C Goodall, A Gwee, T Jamieson, B Jardim, TR Kollmann, MVG Lacerda, KJ Lee, D Legge Show all

BMJ Open | Published : 2021

DOI: 10.1136/bmjopen-2021-052101

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Abstract

Introduction BCG 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 ..

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University of Melbourne Researchers

Laure Pittet Author

Nicole Messina Author

Amanda Gwee Author

Kate Lee Author

Grants

Awarded by Peter Sowerby Foundation

Funding Acknowledgements

This trial is supported by the Bill & Melinda Gates Foundation (INV-017302), the Minderoo Foundation (COV--001), Sarah and Lachlan Murdorch, the Royal Children's Hospital Foundation (2020--1263 BRACE Trial), Health Services Union NSW, the Peter Sowerby Foundation, the Ministry of Health Government of South Australia, the NAB Foundation, the Calvert--Jones Foundation, the Modara Pines Charitable Foundation, the UHG Foundation Pty Ltd, Epworth Healthcare and individual donors. NC is supported by the National Health and Medical Research Council (NHMRC) (Investigator Grant GNT1197117). LFP is supported by the Swiss National Science Foundation (Early Postdoc.Mobility grant number P2GEP3_178155). SB is supported by the University of Melbourne Research and Training Program scholarship and the Clifford Family scholarship. PV is supported by the Australian Government Research Training Program (RTP) Scholarship administered by the University of Melbourne and Murdoch Children's Research Institute PhD Top--Up Scholarship. The Melbourne WHO Collaborating Centre for Reference and Research on Influenza is supported by the Australian Government Department of Health (Health Protection Program Agreement #4--4GFBE88).