| Author | Pittet, Laure F. | |
| Author | Messina, Nicole L. | |
| Author | Gardiner, Kaya | |
| Author | Orsini, Francesca | |
| Author | Abruzzo, Veronica | |
| Author | Bannister, Samantha | |
| Author | Bonten, Marc | |
| Author | Campbell, John L. | |
| Author | Croda, Julio | |
| Author | Dalcomo, Margareth | |
| Author | Elia, Sonja | |
| Author | Germano, Susie | |
| Author | Goodall, Casey | |
| Author | Gwee, Amanda | |
| Author | Jamieson, Tenaya | |
| Author | Jardim, Bruno | |
| Author | Kollman, Tobias R. | |
| Author | Lacerda, Marcus Vinícius Guimarães | |
| Author | Lee, Katherine J. | |
| Author | Legge, Donna | |
| Author | Lucas, Michaela | |
| Author | Lynn, David J. | |
| Author | McDonald, Ellie | |
| Author | Manning, Laurens | |
| Author | Munns, Craig F. | |
| Author | Perrett, Kirsten P. | |
| Author | Aymerich, Cristina Prat | |
| Author | Richmond, Peter | |
| Author | Shann, Frank | |
| Author | Sudbury, Eva | |
| Author | Villanueva, Paola | |
| Author | Wood, Nicholas J. | |
| Author | Lieschke, Katherine | |
| Author | Subbarao, Kanta | |
| Author | Davidson, Andrew | |
| Author | Curtis, Nigel | |
| Author | the BRACE trial Consortium Group | |
| Access date | 2022-03-16T19:21:45Z | |
| Available date | 2022-03-16T19:21:45Z | |
| Document date | 2021 | |
| Citation | PITTET, Laure F. et al. BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial). BMJ Open, v. 11, e052101, p. 1 - 9, 2021. | pt_BR |
| ISSN | 2044-6055 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/51704 | |
| Description | Pesquisadores da Fiocruz: Margareth Dalcomo - Escola Nacional de Saúde Pública Sérgio Arouca (RJ);Julio Croda - Fiocruz Mato Grosso / Universidade Federal do Mato Grosso do Sul. | pt_BR |
| Language | eng | pt_BR |
| Publisher | BMJ Open | pt_BR |
| Rights | open access | |
| Subject in Portuguese | Vacinação BCG | pt_BR |
| Subject in Portuguese | Reduzir o impacto | pt_BR |
| Subject in Portuguese | COVID-19 | pt_BR |
| Subject in Portuguese | Profissionais de saúde | pt_BR |
| Subject in Portuguese | Protocolo | pt_BR |
| Subject in Portuguese | Ensaio controlado randomizado (ensaio BRACE) | pt_BR |
| Title | BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial) | pt_BR |
| Type | Article | |
| DOI | the BRACE trial Consortium Group | |
| 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.
Trial registration ClinicalTrials. gov NCT04327206. | pt_BR |
| Affilliation | Múltiplas - ver em Notas. | pt_BR |
| Subject | BCG vaccination | pt_BR |
| Subject | Reduce impact | pt_BR |
| Subject | COVID-19 | pt_BR |
| Subject | Healthcare workers | pt_BR |
| Subject | Protocol | pt_BR |
| Subject | Randomised controlled trial (BRACE trial) | pt_BR |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
