2022/08/15 by Denise L. Faustman, Amanda J. Lee, Emma R. Hostetter +11 · 1 citation
Immunology and Microbiology · Biochemistry, Genetics and Molecular Biology · Medicine · #Immune responses and vaccinations #Diabetes and associated disorders #COVID-19 Clinical Research Studies
paper · pdf · doi:10.1016/j.xcrm.2022.100728
openalex publication_date 2022/08/15 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/28
There is a need for safe and effective platform vaccines to protect against coronavirus disease 2019 (COVID-19) and other infectious diseases. In this randomized, double-blinded, placebo-controlled phase 2/3 trial, we evaluate the safety and efficacy of a multi-dose Bacillus Calmette-Guérin (BCG) vaccine for the prevention of COVID-19 and other infectious disease in a COVID-19-unvaccinated, at-risk-community-based cohort. The at-risk population is made of up of adults with type 1 diabetes. We enrolled 144 subjects and randomized 96 to BCG and 48 to placebo. There were no dropouts over the 15-month trial. A cumulative incidence of 12.5% of placebo-treated and 1% of BCG-treated participants meets criteria for confirmed COVID-19, yielding an efficacy of 92%. The BCG group also displayed fewer infectious disease symptoms and lesser severity and fewer infectious disease events per patient, including COVID-19. There were no BCG-related systemic adverse events. BCG's broad-based infection protection suggests that it may provide platform protection against new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and other pathogens.