drugset / Trial / NCT04327206
BCG Vaccination to Protect Healthcare Workers Against COVID-19
Phase 3
Completed
6828 enrolled
Murdoch Childrens Research Institute
Bill and Melinda Gates Foundation · collabRoyal Children's Hospital · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
Phase III, two-group multicentre, randomised controlled trial in up to 10 078 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic.
Timeline
- Start
- 2020-03-30
- Primary completion
- 2021-11-10
- Completion
- 2022-05-27
Outcome
Missed primary endpoint
paper The estimated risk of symptomatic Covid-19 by 6 months was 14.7% in the BCG group and 12.3% in the placebo group PMID 37099341 ↗
paper Vaccination with BCG-Denmark did not result in a lower risk of Covid-19 among health care workers than placebo. PMID 37099341 ↗
Publications
- McDonald E, Pittet LF, Bonten M, Byrne A, Campbell J, Croda J, Dalcolmo M, Davidson AJ, Dos Santos G, Gardiner K, Gwee A, Jardim B, Lacerda M, Lucas M, Lynn DJ, Manning L, Marshall H, Perrett KP, Prat-Aymerich C, Puga MAM, Richmond P, Rodriguez-Bano J, Wadia U, Warris A, Wood N, Curtis N, Messina NL; BRACE Trial Consortium Group. Optimising COVID-19 episode identification using serology and PCR/rapid antigen testing: insights from the BRACE trial. BMC Infect Dis. 2026 Apr 7;26(1):974. doi: 10.1186/s12879-026-13128-6.
- Messina NL, Pittet LF, McDonald E, Moore C, Barry S, Bonten M, Byrne A, Campbell J, Croda J, Croda MG, Dalcolmo M, de Almeida E Val FF, de Oliveira RD, Dos Santos G, Douglas MW, Gardiner K, Gwee A, Jardim BA, Kollmann T, Lacerda MV, Lucas M, Lynn DJ, Manning L, Marshall H, O'Connell A, Perrett KP, Post JJ, Prat-Aymerich C, Rocha JL, Rodriguez-Bano J, Wadia U, Warris A, Davidson A, Curtis N; BRACE Trial Consortium Group. BCG vaccination of healthcare workers for protection against COVID-19: 12-month outcomes from an international randomised controlled trial. J Infect. 2024 Oct;89(4):106245. doi: 10.1016/j.jinf.2024.106245. Epub 2024 Aug 8.
- Pittet LF, Messina NL, McDonald E, Orsini F, Barry S, Bonten M, Campbell J, Croda J, Croda MG, Dalcolmo M, Gardiner K, Gwee A, Jardim B, Lacerda MVG, Lucas M, Lynn DJ, Manning L, Perrett KP, Post JJ, Prat-Aymerich C, Richmond PC, Rocha JL, Rodriguez-Bano J, Warris A, Wood NJ, Davidson A, Curtis N; BRACE Trial Consortium Group. Bacille Calmette-Guerin vaccination to prevent febrile and respiratory illness in adults (BRACE): secondary outcomes of a randomised controlled phase 3 trial. EClinicalMedicine. 2024 May 13;72:102616. doi: 10.1016/j.eclinm.2024.102616. eCollection 2024 Jun.
- Dos Santos PCP, Messina NL, de Oliveira RD, da Silva PV, Puga MAM, Dalcolmo M, Dos Santos G, de Lacerda MVG, Jardim BA, de Almeida E Val FF, Curtis N, Andrews JR, Croda J. Effect of BCG vaccination against Mycobacterium tuberculosis infection in adult Brazilian health-care workers: a nested clinical trial. Lancet Infect Dis. 2024 Jun;24(6):594-601. doi: 10.1016/S1473-3099(23)00818-6. Epub 2024 Feb 26.
- Pittet LF, Moore CL, McDonald E, Barry S, Bonten M, Campbell J, Croda J, Dalcolmo M, Davidson A, Douglas MW, Gardiner K, Gwee A, Jardim B, Lacerda MVG, Lucas M, Lynn DJ, Manning L, de Oliveira RD, Perrett KP, Prat-Aymerich C, Richmond PC, Rocha JL, Rodriguez-Bano J, Warris A, Wood NJ, Messina NL, Curtis N; BRACE Trial Consortium Group. Bacillus Calmette-Guerin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trial. EClinicalMedicine. 2023 Sep 11;64:102203. doi: 10.1016/j.eclinm.2023.102203. eCollection 2023 Oct.
- Pittet LF, Messina NL, Orsini F, Moore CL, Abruzzo V, Barry S, Bonnici R, Bonten M, Campbell J, Croda J, Dalcolmo M, Gardiner K, Gell G, Germano S, Gomes-Silva A, Goodall C, Gwee A, Jamieson T, Jardim B, Kollmann TR, Lacerda MVG, Lee KJ, Lucas M, Lynn DJ, Manning L, Marshall HS, McDonald E, Munns CF, Nicholson S, O'Connell A, de Oliveira RD, Perlen S, Perrett KP, Prat-Aymerich C, Richmond PC, Rodriguez-Bano J, Dos Santos G, da Silva PV, Teo JW, Villanueva P, Warris A, Wood NJ, Davidson A, Curtis N; BRACE Trial Consortium Group. Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers. N Engl J Med. 2023 Apr 27;388(17):1582-1596. doi: 10.1056/NEJMoa2212616.
- Pittet LF, Messina NL, Gardiner K, Orsini F, Abruzzo V, Bannister S, Bonten M, Campbell JL, Croda J, Dalcolmo M, Elia S, Germano S, Goodall C, Gwee A, Jamieson T, Jardim B, Kollmann TR, Guimaraes Lacerda MV, Lee KJ, Legge D, Lucas M, Lynn DJ, McDonald E, Manning L, Munns CF, Perrett KP, Prat Aymerich C, Richmond P, Shann F, Sudbury E, Villanueva P, Wood NJ, Lieschke K, Subbarao K, Davidson A, Curtis N; BRACE trial Consortium Group. BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial). BMJ Open. 2021 Oct 28;11(10):e052101. doi: 10.1136/bmjopen-2021-052101.
- Crisan-Dabija R, Grigorescu C, Pavel CA, Artene B, Popa IV, Cernomaz A, Burlacu A. Tuberculosis and COVID-19: Lessons from the Past Viral Outbreaks and Possible Future Outcomes. Can Respir J. 2020 Sep 5;2020:1401053. doi: 10.1155/2020/1401053. eCollection 2020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCG vaccine | Vaccine | 0.1 ml | Intrathecal |