BCG vaccination to reduce the impact of COVID-19 in healthcare workers : Protocol for a randomised controlled trial (BRACE trial)
Pittet, Laure F (The Royal Children's Hospital Melbourne)
Messina, Nicole L (The University of Melbourne)
Gardiner, Kaya (Murdoch Children's Research Institute)
Orsini, Francesca (Murdoch Children's Research Institute)
Abruzzo, Veronica (Murdoch Children's Research Institute)
Bannister, Samantha (The Royal Children's Hospital Melbourne)
Bonten, Marc (Julius Center for Health Sciences and Primary Care)
Campbell, John L (University of Exeter Medical School)
Croda, Julio (Yale School of Public Health)
Dalcolmo, Margareth (Pontifical Catholic University of Rio de Janeiro)
Elia, Sonja (The Royal Children's Hospital Melbourne)
Germano, Susie (Murdoch Children's Research Institute)
Goodall, Casey (Murdoch Children's Research Institute)
Gwee, Amanda (The Royal Children's Hospital Melbourne)
Jamieson, Tenaya (Murdoch Children's Research Institute)
Jardim, Bruno (Fundação de Medicina Tropical Doutor Heitor Vieira Dourado)
Kollmann, Tobias R (Telethon Kids Institute)
Guimarães Lacerda, Marcus Vinícius (Fundação Oswaldo Cruz (Brasil))
Lee, Katherine J (Murdoch Children's Research Institute)
Legge, Donna (Royal Children's Hospital Melbourne)
Lucas, Michaela (The University of Western Australia)
Lynn, David J (Flinders University)
McDonald, Ellie (Murdoch Children's Research Institute)
Manning, Laurens (Fiona Stanley Hospital (Perth, Austràlia))
Munns, Craig F (The University of Sydney)
Perrett, Kirsten P (Murdoch Children's Research Institute)
Prat i Aymerich, Cristina (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Richmond, Peter (The University of Western Australia)
Shann, Frank (The Royal Children's Hospital Melbourne)
Sudbury, Eva (Murdoch Children's Research Institute)
Villanueva, Paola (The University of Melbourne)
Wood, Nicholas J (National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases)
Lieschke, Katherine (Murdoch Children's Research Institute)
Subbarao, Kanta (The Peter Doherty Institute for Infection and Immunity)
Davidson, Andrew (Murdoch Children's Research Institute)
Curtis, Nigel (The Royal Children's Hospital Melbourne)
Universitat Autònoma de Barcelona

Data:	2021
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	COVID-19 ; Immunology ; Infectious diseases ; Microbiology ; Virology
Publicat a:	BMJ open, Vol. 11 (october 2021) , ISSN 2044-6055

DOI: 10.1136/bmjopen-2021-052101
PMID: 34711598

9 p, 1.2 MB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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