BCG-PRIME
Trial question
What is the role of BCG vaccine in older adults with underlying comorbidities?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 6112
6112 patients (2275 female, 3837 male).
Inclusion criteria: adults > 60 years of age with ≥ 1 underlying comorbidities and no contraindications for BCG vaccination.
Key exclusion criteria: history of documented COVID-19; known history of a positive Mantoux or active tuberculosis; severely immunocompromised state; vaccination with a live vaccine in the past 4 weeks, or planned vaccination with a live vaccine during the next 4 weeks.
Interventions
N=3058 BCG (0.1 mL of BCG vaccine via intradermal injection in the left upper arm).
N=3054 placebo (0.1 mL saline via intradermal injection in the left upper arm).
Primary outcome
COVID-19 infection
4.2%
3.8%
4.2 %
3.2 %
2.1 %
1.1 %
0.0 %
BCG
Placebo
No significant
difference ↔
No significant difference in COVID-19 infection (4.2% vs. 3.8%; HR 1.12, 95% CI 0.87 to 1.44).
Secondary outcomes
No significant difference in COVID-19-related hospitalization (0.6% vs. 0.7%; HR 0.86, 95% CI 0.46 to 1.61).
No significant difference in clinically relevant respiratory tract infection (2.2% vs. 2.4%; HR 0.92, 95% CI 0.66 to 1.28).
No significant difference in respiratory tract infection-related hospital admission (0.85% vs. 0.94%; HR 0.9, 95% CI 0.53 to 1.53).
Safety outcomes
No significant difference in all-cause mortality at 6 months.
Conclusion
In adults > 60 years of age with ≥ 1 underlying comorbidities and no contraindications for BCG vaccination, BCG was not superior to placebo with respect to a COVID-19 infection.
Reference
Eva L Koekenbier, Konstantin Fohse, Josephine S van de Maat et al. Bacillus Calmette-Guérin vaccine for prevention of COVID-19 and other respiratory tract infections in older adults with comorbidities: a randomized controlled trial. Clin Microbiol Infect. 2023 Jun;29(6):781-788.
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