BRACE (COVID-19)
Trial question
What is the role of the BCG vaccine in healthcare workers?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
75.0% female
25.0% male
N = 3386
3386 patients (2526 female, 860 male)
Inclusion criteria: healthcare workers
Key exclusion criteria: previous positive SARS-CoV-2 test; contraindication to BCG vaccine; receipt of BCG vaccine within the past year; any other live-attenuated vaccine within the past month
Interventions
N=1703 BCG vaccine (receipt of BCG-Denmark vaccine with a follow-up for 12 months)
N=1683 placebo (receipt of matching placebo with a follow-up for 12 months)
Primary outcome
Rate of symptomatic coronavirus disease 2019 by 6 months
14.7
12.3
14.7 %
11.0 %
7.3 %
3.7 %
0.0 %
BCG
vaccine
Placebo
No significant
difference ↔
No significant difference in the rate of symptomatic COVID-19 by 6 months (14.7% vs. 12.3%; AD 2.4%, 95% CI -0.7 to 5.5)
Secondary outcomes
No significant difference in the rate of risk of severe COVID-19 by 6 months (7.6% vs. 6.5%; AD 1.1%, 95% CI -1.2 to 3.5)
No significant difference in symptomatic or severe COVID-19 (7.9% vs. 6.4%; HR 1.23, 95% CI 0.96 to 1.59)
No significant difference in pneumonia due to COVID-19 (0.4% vs. 0.4%; HR 0.93, 95% CI 0.32 to 2.64)
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In healthcare workers, BCG vaccine was not superior to placebo with respect to the rate of symptomatic COVID-19 by 6 months.
Reference
Laure F Pittet, Nicole L Messina, Francesca Orsini et al. Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers. N Engl J Med. 2023 Apr 27;388(17):1582-1596.
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