Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers

LF Pittet; NL Messina; F Orsini; CL Moore; V Abruzzo; S Barry; R Bonnici; M Bonten; J Campbell; J Croda; M Dalcolmo; K Gardiner; G Gell; S Germano; A Gomes-Silva; C Goodall; A Gwee; T Jamieson; B Jardim; TR Kollmann; MVG Lacerda; KJ Lee; M Lucas; DJ Lynn; L Manning; HS Marshall; E McDonald; CF Munns; S Nicholson; A O'Connell; RD De Oliveira; S Perlen; KP Perrett; C Prat-Aymerich; PC Richmond; J Rodriguez-Baño; G Dos Santos; PV Da Silva; JW Teo; P Villanueva; A Warris; NJ Wood; A Davidson; N Curtis

Journal article

Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers

LF Pittet, NL Messina, F Orsini, CL Moore, V Abruzzo, S Barry, R Bonnici, M Bonten, J Campbell, J Croda, M Dalcolmo, K Gardiner, G Gell, S Germano, A Gomes-Silva, C Goodall, A Gwee, T Jamieson, B Jardim, TR Kollmann Show all

New England Journal of Medicine | Published : 2023

DOI: 10.1056/NEJMoa2212616

Abstract

Background The bacille Calmette-Guérin (BCG) vaccine has immunomodulatory "off-target"effects that have been hypothesized to protect against coronavirus disease 2019 (Covid-19). Methods In this international, double-blind, placebo-controlled trial, we randomly assigned health care workers to receive the BCG-Denmark vaccine or saline placebo and followed them for 12 months. Symptomatic Covid-19 and severe Covid-19, the primary outcomes, were assessed at 6 months; the primary analyses involved the modified intention-to-treat population, which was restricted to participants with a negative test for severe acute respiratory syndrome coronavirus 2 at baseline. Results A total of 3988 participants..

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University of Melbourne Researchers

Laure Pittet Author

Nicole Messina Author

Francesca Orsini Author

Amanda Gwee Author

Grants

Awarded by State Government of Victoria

Funding Acknowledgements

Supported by grants from the Bill and Melinda Gates Foundation (INV-017302), the Minderoo Foundation (COV-001), the Royal Children's Hospital Foundation (2020-1263 BRACE Trial), the Australian National Health and Medical Research Council (1194694, to Dr. Gwee; 1127984, to Dr. Lee; 2008911, to Dr. Per-rett; 1155066, to Dr. Marshall; and 1197117, to Dr. Curtis), the Swiss National Science Foundation (P2GEP3_178155, to Dr. Pittet), EMBL Australia (to Dr. Lynn), and the U.K. Medical Re-search Council (MR/N006364/2, to Dr. Warris) and by Sarah and Lachlan Murdoch, Health Services Union NSW, the Peter Sowerby Foundation, SA Health, the Insurance Advisernet Foundation, the NAB Foundation, the Calvert-Jones Foundation, the Modara Pines Charitable Foundation, the UHG Foundation, Epworth HealthCare, and individual donors. The Murdoch Children's Research Institute leads the BRACE trial across 36 sites in five countries; it is supported by the Victorian Government Operational Infrastructure Support Programme.