Evidence map›Paper›PMID 39127450›Full record

Trial reportThe Journal of infection2024

BCG vaccination of healthcare workers for protection against COVID-19: 12-month outcomes from an international randomised controlled trial.

Nicole L Messina, Laure F Pittet, Ellie McDonald, Cecilia Moore, Simone Barry, Marc Bonten, Anthony Byrne, John Campbell, Julio Croda, Mariana G Croda and 25 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infection, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04327206 (BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04327206 phase3completednot on this map

BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (BRACE) Trial

TypeinterventionalSponsorMurdoch Childrens Research InstituteRan2020 to 2022Enrolled6,828ConditionsCoronavirus Disease 2019 (COVID-19), Respiratory Illness, Corona Virus Infection, COVID-19ArmsBCG Vaccine, 0.9%NaCl
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

35 authors.

Nicole L MessinaInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia.
Laure F PittetInfectious 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 Medicine, Geneva, Switzerland.
Ellie McDonaldInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Cecilia MooreClinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Simone BarryPrecision Medicine Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia; Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Marc BontenJulius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, the Netherlands; European Clinical Research Alliance on Infectious Diseases, Utrecht, Netherlands.
Anthony ByrneSt 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.
John CampbellExeter Collaboration for Academic Primary Care, University of Exeter Medical School, Exeter, United Kingdom.
Julio CrodaFiocruz 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.
Mariana G CrodaUniversidade Federal de Mato Grosso do Sul, Campo Grande, Mato Grosso do Sul, Brazil.
Margareth DalcolmoCentro de Referência Professor Hélio Fraga, ENSP/FIOCRUZ (Fundação Oswaldo Cruz), Rio de Janeiro, Brazil.
Fernando F de Almeida E ValTropical Medicine Foundation Dr Heitor Vieira Dourado, Manaus, Brazil.
Roberto D de OliveiraState University of Mato Grosso do Sul, Dourados, Brazil; Post Graduate Program in Health Sciences, Federal University of Grande Dourados, Dourados, Brazil.
Glauce Dos SantosCentro de Referência Professor Hélio Fraga, ENSP/FIOCRUZ (Fundação Oswaldo Cruz), Rio de Janeiro, Brazil.
Mark W DouglasStorr 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 South Wales, Australia.
Kaya GardinerInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Research Operations, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
Amanda GweeDepartment 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.
Bruno A JardimInstitute of Clinical Research Carlos Borborema, Doctor Heitor Vieira Dourado Tropical Medicine Foundation, Manaus, Brazil.
Tobias KollmannWesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia.
Marcus Vg LacerdaInstitute 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.
Michaela LucasDepartment 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; School of Medicine, University of Western Australia, Perth, Western Australia, Australia.
David J LynnPrecision 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.
Laurens ManningWesfarmers 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, Australia.
Helen MarshallThe University of Adelaide and the Women's and Children's Health Network, Adelaide, SA, Australia.
Abby O'ConnellExeter Clinical Trials Unit, University of Exeter, Exeter, United Kingdom.
Kirsten P PerrettDepartment 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.
Jeffrey J PostDepartment 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.
Cristina Prat-AymerichJulius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, the Netherlands; European Clinical Research Alliance on Infectious Diseases, Utrecht, Netherlands.
Jorge L RochaHelio Fraga Reference Center, Oswaldo Cruz Foundation Ministry of Health, Curicica, Brazil.
Jesus Rodriguez-BañoDivision 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 III, Madrid, Spain.
Ushma WadiaWesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia; School of Medicine, University of Western Australia, Perth, Western Australia, Australia.
Adilia WarrisMedical Research Council Centre for Medical Mycology, University of Exeter, Exeter, United Kingdom; Department of Infectious Diseases, Great Ormond Street Hospital, London, United Kingdom.
Andrew DavidsonMelbourne Children's Trial Centre, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Nigel CurtisInfectious 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: nigel.curtis@rch.org.au.
BRACE Trial Consortium Group

Funding

Gates Foundation INV-017302
6 · The paper itself

Abstract

objectivesBacille 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.

designPhase III double-blind randomised controlled trial.

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

participants3988 healthcare workers with no prior COVID-19 and no contraindication to BCG.

interventionRandomised 1:1 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 measuresDifference 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).

resultsOf 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.

conclusionsCompared 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 registrationClinicalTrials.gov NCT04327206.

Indexed as

BCG VaccineCOVID-19Health PersonnelSARS-CoV-2AdultAustraliaBrazilDouble-Blind MethodFemaleHumansMaleMiddle AgedSpainUnited KingdomVaccinationBCG VaccineBacille Calmette-Guérin (BCG) VaccineBreakthrough infectionCOVID-19ImmunityRandomised controlled trial

Identifiers

PMID39127450
PMCPMC11409612

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.