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BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial).
Pittet, Laure F; Messina, Nicole L; Gardiner, Kaya; Orsini, Francesca; Abruzzo, Veronica; Bannister, Samantha; Bonten, Marc; Campbell, John L; Croda, Julio; Dalcolmo, Margareth; Elia, Sonja; Germano, Susie; Goodall, Casey; Gwee, Amanda; Jamieson, Tenaya; Jardim, Bruno; Kollmann, Tobias R; Guimarães Lacerda, Marcus Vinícius; Lee, Katherine J; Legge, Donna; Lucas, Michaela; Lynn, David J; McDonald, Ellie; Manning, Laurens; Munns, Craig F; Perrett, Kirsten P; Prat Aymerich, Cristina; Richmond, Peter; Shann, Frank; Sudbury, Eva; Villanueva, Paola; Wood, Nicholas J; Lieschke, Katherine; Subbarao, Kanta; Davidson, Andrew; Curtis, Nigel.
  • Pittet LF; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Messina NL; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
  • Gardiner K; Infectious Diseases, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
  • Orsini F; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Abruzzo V; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
  • Bannister S; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Bonten M; Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Campbell JL; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Croda J; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Dalcolmo M; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
  • Elia S; Infectious Diseases, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
  • Germano S; University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands.
  • Goodall C; University of Exeter Medical School, Exeter, UK.
  • Gwee A; Oswaldo Cruz Foundation, Campo Grande, Mato Grosso do Sul, Brazil.
  • Jamieson T; School of Medicine, Federal University of Mato Grosso do Sul, Campo Grande, Mato Grosso do Sul, Brazil.
  • Jardim B; Yale School of Public Health, New Haven, Connecticut, USA.
  • Kollmann TR; Helio Fraga Reference Center, Oswaldo Cruz Foundation Ministry of Health, Rio de Janeiro, Brazil.
  • Guimarães Lacerda MV; Pontifical Catholic University of Rio de Janeiro, Rio de Janeiro, Brazil.
  • Lee KJ; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Legge D; Immunisation Service, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
  • Lucas M; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Lynn DJ; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • McDonald E; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Manning L; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
  • Munns CF; Infectious Diseases, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
  • Perrett KP; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Prat Aymerich C; Institute of Clinical Research Carlos Borborema, Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Amazonas, Brazil.
  • Richmond P; Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Western Australia, Australia.
  • Shann F; Institute of Clinical Research Carlos Borborema, Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Amazonas, Brazil.
  • Sudbury E; Instituto Leônidas & Maria Deane, Oswaldo Cruz Foundation, Manaus, Amazonas, Brazil.
  • Villanueva P; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
  • Wood NJ; Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Lieschke K; Department of Pharmacy, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
  • Subbarao K; Department of Immunology, QE2 Medical Centre, PathWest Laboratory Medicine Western Australia, Nedlands, Western Australia, Australia.
  • Davidson A; Department of Immunology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
  • Curtis N; Department of Immunology and General Paediatrics, Perth Children's Hospital, Nedlands, Western Australia, Australia.
BMJ Open ; 11(10): e052101, 2021 10 28.
Article in English | MEDLINE | ID: covidwho-1495466
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 11 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: BCG Vaccine / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2021-052101

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Full text: Available Collection: International databases Database: MEDLINE Main subject: BCG Vaccine / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2021-052101