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BCG vaccination of healthcare workers for protection against COVID-19: 12-month outcomes from an international randomised controlled trial.
Messina, Nicole L; Pittet, Laure F; McDonald, Ellie; Moore, Cecilia; Barry, Simone; Bonten, Marc; Byrne, Anthony; Campbell, John; Croda, Julio; Croda, Mariana G; Dalcolmo, Margareth; de Almeida E Val, Fernando F; de Oliveira, Roberto D; Dos Santos, Glauce; Douglas, Mark W; Gardiner, Kaya; Gwee, Amanda; Jardim, Bruno A; Kollmann, Tobias; Lacerda, Marcus Vg; Lucas, Michaela; Lynn, David J; Manning, Laurens; Marshall, Helen; O'Connell, Abby; Perrett, Kirsten P; Post, Jeffrey J; Prat-Aymerich, Cristina; Rocha, Jorge L; Rodriguez-Baño, Jesus; Wadia, Ushma; Warris, Adilia; Davidson, Andrew; Curtis, Nigel.
Affiliation
  • Messina NL; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
  • Pittet LF; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Immunology, Vaccinology, Rheumatology and Infectious Diseases Unit, Geneva and University Hospitals and Faculty of
  • McDonald E; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Moore C; Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Barry S; Precision Medicine Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia; Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
  • Bonten M; Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, the Netherlands; European Clinical Research Alliance on Infectious Diseases, Utrecht, Netherlands.
  • Byrne A; St Vincent's Hospitals, Darlinghurst, New South Wales, Australia; Partners In Health, Socios En Salud, Peru; Thoracic Society of Australia & New Zealand (NSW/ACT Branch), Australia.
  • Campbell J; Exeter Collaboration for Academic Primary Care, University of Exeter Medical School, Exeter, United Kingdom.
  • Croda J; Fiocruz Mato Grosso do Sul, Fundação Oswaldo Cruz, Campo Grande, Mato Grosso do Sul, Brazil; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA; Universidade Federal de Mato Grosso do Sul, Campo Grande, Mato Grosso do Sul, Brazil.
  • Croda MG; Universidade Federal de Mato Grosso do Sul, Campo Grande, Mato Grosso do Sul, Brazil.
  • Dalcolmo M; Centro de Referência Professor Hélio Fraga, ENSP/FIOCRUZ (Fundação Oswaldo Cruz), Rio de Janeiro, Brazil.
  • de Almeida E Val FF; Tropical Medicine Foundation Dr Heitor Vieira Dourado, Manaus, Brazil.
  • de Oliveira RD; State University of Mato Grosso do Sul, Dourados, Brazil; Post Graduate Program in Health Sciences, Federal University of Grande Dourados, Dourados, Brazil.
  • Dos Santos G; Centro de Referência Professor Hélio Fraga, ENSP/FIOCRUZ (Fundação Oswaldo Cruz), Rio de Janeiro, Brazil.
  • Douglas MW; Storr Liver Centre, The Westmead Institute for Medical Research, The University of Syndey at Westmead Hospital, Westmead, New South Wales, Australia; Centre for Infectious Diseases and Microbiology, Sydney Infectious Diseases Institute, The University of Sydney at Westmead Hospital, Westmead, New So
  • Gardiner K; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Research Operations, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
  • Gwee A; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Infectious Diseases, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia; Antimicrobials Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Jardim BA; Institute of Clinical Research Carlos Borborema, Doctor Heitor Vieira Dourado Tropical Medicine Foundation, Manaus, Brazil.
  • Kollmann T; Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia.
  • Lacerda MV; Institute of Clinical Research Carlos Borborema, Doctor Heitor Vieira Dourado Tropical Medicine Foundation, Manaus, Brazil; Instituto Leônidas & Maria Deane, Oswaldo Cruz Foundation Ministry of Health, Manaus, Brazil; University of Texas Medical Branch, Galveston, TX, USA.
  • Lucas M; Department of Immunology, Pathwest, Queen Elizabeth II Medical Centre, Nedlands, Western Australia, Australia; Department of Immunology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia; Department of Immunology, Perth Children's Hospital, Nedlands, Western Australia, Australia;
  • Lynn DJ; Precision Medicine Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia; Flinders Health and Medical Research Institute, Flinders University, Bedford Park, South Australia, Australia.
  • Manning L; Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia; School of Medicine, University of Western Australia, Perth, Western Australia, Australia; Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, Western Australia, Au
  • Marshall H; The University of Adelaide and the Women's and Children's Health Network, Adelaide, SA, Australia.
  • O'Connell A; Exeter Clinical Trials Unit, University of Exeter, Exeter, United Kingdom.
  • Perrett KP; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Population Allergy Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Allergy and Immunology, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
  • Post JJ; Department of Infectious Diseases, Prince of Wales Hospital, Randwick, New South Wales, Australia; School of Clinical Medicine, University of New South Wales, Sydney, New South Wales, Australia.
  • Prat-Aymerich C; Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, the Netherlands; European Clinical Research Alliance on Infectious Diseases, Utrecht, Netherlands.
  • Rocha JL; Helio Fraga Reference Center, Oswaldo Cruz Foundation Ministry of Health, Curicica, Brazil.
  • Rodriguez-Baño J; Division of Infectious Diseases and Microbiology, Department of Medicine, Hospital Universitario Virgen Macarena, University of Seville, Biomedicines Institute of Seville-Consejo Superior de Investigaciones Científicas, Seville, Spain; CIBER de Enfermedades Infecciosas, Instituto de Salud Carloss II
  • Wadia U; Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia; School of Medicine, University of Western Australia, Perth, Western Australia, Australia.
  • Warris A; Medical Research Council Centre for Medical Mycology, University of Exeter, Exeter, United Kingdom; Department of Infectious Diseases, Great Ormond Street Hospital, London, United Kingdom.
  • Davidson A; Melbourne Children's Trial Centre, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
  • Curtis N; Infectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Infectious Diseases, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia. Electronic address: nige
J Infect ; 89(4): 106245, 2024 Oct.
Article in En | MEDLINE | ID: mdl-39127450
ABSTRACT

OBJECTIVES:

Bacille Calmette-Guérin (BCG) vaccine has immunomodulatory effects that may provide protection against unrelated infectious diseases. We aimed to determine whether BCG vaccination protects adults against COVID-19.

DESIGN:

Phase III double-blind randomised controlled trial.

SETTING:

Healthcare centres in Australia, Brazil, the Netherlands, Spain, and the United Kingdom during the COVID-19 pandemic.

PARTICIPANTS:

3988 healthcare workers with no prior COVID-19 and no contraindication to BCG. INTERVENTION Randomised 11 using a web-based procedure to receive a single 0.1 mL intradermal dose of BCG-Denmark (BCG group, n = 1999) or saline (placebo group, n = 1989). MAIN OUTCOME

MEASURES:

Difference in incidence of (i) symptomatic and (ii) severe COVID-19 during the 12 months following randomisation in the modified intention to treat (mITT) population (confirmed SARS-CoV-2 naïve at inclusion).

RESULTS:

Of the 3988 participants randomised, 3386 had a negative baseline SARS-CoV-2 test and were included in the mITT population. The 12-month adjusted estimated risk of symptomatic COVID-19 was higher in the BCG group (22.6%; 95% confidence interval [CI] 20.6 to 24.5%) compared with the placebo group (19.6%; 95% CI 17.6 to 21.5%); adjusted difference +3.0% points (95% CI 0.2 to 5.8%; p = 0.04). The 12-month adjusted estimated risk of severe COVID-19 (mainly comprising those reporting being unable to work for ≥3 consecutive days) was 11.0% in the BCG group (95% CI 9.5 to 12.4%) compared with 9.6% in the placebo group (95% CI 8.3 to 11.1%); adjusted difference +1.3% points (95% CI -0.7 to 3.3%, p = 0.2). Breakthrough COVID-19 (post COVID-19 vaccination) and asymptomatic SARS-CoV-2 infections were similar in the two groups. There were 18 hospitalisations due to COVID-19 (11 in BCG group, 7 in placebo group; adjusted hazard ratio 1.56, 95% CI 0.60 to 4.02, p = 0.4) and two deaths due to COVID-19, both in the placebo group.

CONCLUSIONS:

Compared to placebo, vaccination with BCG-Denmark increased the risk of symptomatic COVID-19 over 12 months among healthcare workers and did not decrease the risk of severe COVID-19 or post-vaccination breakthrough COVID-19. TRIAL REGISTRATION ClinicalTrials.gov NCT04327206.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: BCG Vaccine / Health Personnel / SARS-CoV-2 / COVID-19 Limits: Adult / Female / Humans / Male / Middle aged Country/Region as subject: America do sul / Brasil / Europa / Oceania Language: En Journal: J Infect / J. infect / Journal of infection Year: 2024 Document type: Article Affiliation country: Australia Country of publication: United kingdom
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: BCG Vaccine / Health Personnel / SARS-CoV-2 / COVID-19 Limits: Adult / Female / Humans / Male / Middle aged Country/Region as subject: America do sul / Brasil / Europa / Oceania Language: En Journal: J Infect / J. infect / Journal of infection Year: 2024 Document type: Article Affiliation country: Australia Country of publication: United kingdom