BCG vaccination of healthcare workers for protection against COVID-19: 12-month outcomes from an international randomised controlled trial.
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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, BRACE Trial Consortium Group
Аннотация
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 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 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.