6/27/23, 11:42 PM BCG-PRIME Pathway Feedback Search Clinical Topics Home Studies BCG PRIME BCG PRIME Disease COVID 19 infection 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 N = 6112 63.0% male 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 % 4.2 3.8 3 2 % https://web.pathway.md/studies/recUroOupT9fxVA2W 1/2 6/27/23, 11:42 PM BCG-PRIME Pathway 3.2 % 2.1 % 1.1 % No significant difference 0.0 % BCG Placebo 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 death from all causes 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 writing committee for the BCG-PRIME study group, Writing committee, Eva L Koekenbier et al. Bacillus Calmette-Gu rin vaccine for prevention of COVID-19 and other respiratory tract infections in older adults with comorbidities: a randomized controlled trial. Clin Microbiol Infect. 2023 Jan 31;S1198-743X(23)00044-7. Open reference URL https://web.pathway.md/studies/recUroOupT9fxVA2W 2/2