BRACE (pulmonary tuberculosis)
Trial question
What is the effect of BCG vaccination for pulmonary tuberculosis in healthcare workers?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
74.0% female
26.0% male
N = 1985
1985 patients (1475 female, 510 male).
Inclusion criteria: adult healthcare workers in a population with a high incidence of tuberculosis.
Key exclusion criteria: contraindications to BCG vaccination; > 1 month of treatment with specific tuberculosis treatment; previous adverse reactions to BCG; recent BCG vaccination; non-compliance with assigned interventions.
Interventions
N=996 BCG vaccine (0.1 mL intradermal injection of BCG [Danish strain 1331]).
N=989 placebo vaccine (intradermal injection of 0.9% saline).
Primary outcome
Interferon-gamma release assay (QuantiFERON-TB Gold Plus) conversion at 12 months
3.4%
3.2%
3.4 %
2.5 %
1.7 %
0.8 %
0.0 %
BCG
vaccine
Placebo
vaccine
No significant
difference ↔
No significant difference in IGRA (QuantiFERON-TB Gold Plus) conversion at 12 months (3.4% vs. 3.2%; RR 1.09, 95% CI 0.67 to 1.77).
Secondary outcomes
No significant difference in sustained conversion (1.5% vs. 1.9%; RR 0.8, 95% CI 0.41 to 1.57).
No significant difference in IGRA conversion with a positivity threshold ≥ 0.70 IU/mL (1.5% vs. 1.3%; RR 1.15, 95% CI 0.55 to 2.45).
No significant difference in IGRA conversion with a positivity threshold ≥ 2.00 IU/mL (0.6% vs. 0.5%; RR 1.18, 95% CI 0.36 to 3.85).
Conclusion
In adult healthcare workers in a population with a high incidence of tuberculosis, BCG vaccine was not superior to placebo vaccine with respect to a IGRA (QuantiFERON-TB Gold Plus) conversion at 12 months.
Reference
Paulo Cesar Pereira Dos Santos, Nicole Louise Messina, Roberto Dias de Oliveira et al. Effect of BCG vaccination against Mycobacterium tuberculosis infection in adult Brazilian health-care workers: a nested clinical trial. Lancet Infect Dis. 2024 Jun;24(6):594-601.
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