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 Campbell, Julio Croda, Margareth Dalcolmo, Sonja Elia, Susie Germano, Casey Goodall, Amanda Gwee, Tenaya Jamieson, Bruno Jardim, Tobias R. Kollmann, Marcus Vinícius Guimarães Lacerda, Katherine J. Lee, Donna LeggeMichaela Lucas, David J. Lynn, Ellie McDonald, Laurens Manning, Craig F. Munns, Kirsten P. Perrett, Cristina Prat Aymerich, Peter Richmond, Frank Shann, Eva Sudbury, Paola Villanueva, Nicholas J. Wood, Katherine Lieschke, Kanta Subbarao, Andrew Davidson, Nigel Curtis, BRACE Trial Consortium Group

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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 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.

Original languageEnglish
Article numbere052101
Number of pages10
JournalBMJ Open
Volume11
Issue number10
DOIs
Publication statusPublished - Oct 2021

Keywords

  • COVID-19
  • immunology
  • infectious diseases
  • microbiology
  • virology

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