BCG vaccination to reduce the impact of COVID-19 in healthcare workers

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 o...

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Autores: Pittet, Laure F.|||0000-0002-2395-4574, Messina, Nicole L.|||0000-0001-8404-4462, Gardiner, Kaya|||0000-0001-9796-4567, Orsini, Francesca, Abruzzo, Veronica, Bannister, Samantha|||0000-0001-7507-3704, Bonten, Marc, Campbell, John L.|||0000-0002-6752-3493, Croda, Julio, Dalcolmo, Margareth|||0000-0002-6820-1082, Elia, Sonja|||0000-0002-6368-189X, Germano, Susie|||0000-0001-9924-7545, Goodall, Casey, Gwee, Amanda|||0000-0003-4016-8986, Jamieson, Tenaya, Jardim, Bruno|||0000-0003-3465-7556, Kollmann, Tobias R.|||0000-0003-2403-9762, Guimarães Lacerda, Marcus Vinícius|||0000-0003-3374-9985, Lee, Katherine J.|||0000-0002-8334-0291, Legge, Donna, Lucas, Michaela|||0000-0001-8881-9990, Lynn, David J.|||0000-0003-4664-1404, McDonald, Ellie|||0000-0003-2295-4641, Manning, Laurens|||0000-0003-4334-5351, Munns, Craig F.|||0000-0001-5898-5808, Perrett, Kirsten P.|||0000-0002-5683-996X, Prat i Aymerich, Cristina|||0000-0001-6974-9165, Richmond, Peter|||0000-0001-7562-7228, Shann, Frank|||0000-0002-9899-1804, Sudbury, Eva, Villanueva, Paola|||0000-0002-6504-2979, Wood, Nicholas J., Lieschke, Katherine, Subbarao, Kanta|||0000-0003-1713-3056, Davidson, Andrew, Curtis, Nigel|||0000-0003-3446-4594
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:282522
Acceso en línea:https://ddd.uab.cat/record/282522
https://dx.doi.org/urn:doi:10.1136/bmjopen-2021-052101
Access Level:acceso abierto
Palabra clave:COVID-19
Immunology
Infectious diseases
Microbiology
Virology
Descripción
Sumario: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. 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. 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. ClinicalTrials.gov.

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