Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes

• Published in: Cell reports. Medicine Vol. 3; no. 9; p. 100728
• Main Authors: Faustman, Denise L., Lee, Amanda, Hostetter, Emma R., Aristarkhova, Anna, Ng, Nathan C., Shpilsky, Gabriella F., Tran, Lisa, Wolfe, Grace, Takahashi, Hiroyuki, Dias, Hans F., Braley, Joan, Zheng, Hui, Schoenfeld, David A., Kühtreiber, Willem M.
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 20.09.2022; Elsevier
• Subjects: Advanced Basic Science; autoimmune; Bacillus Calmette-Guérin; BCG; Clinicaltrials.gov: NCT02081326; COVID-19; host microbe interactions; hygiene hypothesis; infectious diseases; phase 2/3 trial; randomized double blinded clinical trial; type 1 diabetes; vaccine; COVID-19; Bacillus Calmette-Guérin; host microbe interactions; type 1 diabetes; vaccine; hygiene hypothesis; autoimmune; randomized double blinded clinical trial; BCG; infectious diseases; Clinicaltrials.gov: NCT02081326; phase 2/3 trial
• ISSN: 2666-3791; 2666-3791
• DOI: 10.1016/j.xcrm.2022.100728

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. [Display omitted] •We report on our randomized trial of multi-dose BCG for protection against COVID-19•BCG is safe and has 92% efficacy versus placebo against COVID-19•Findings also suggest platform protection against additional infectious diseases•Efficacy takes 1–2 years to manifest, but the protection may last decades In a randomized, double-blinded, placebo-controlled phase 2/3 trial, Faustman et al. investigate the safety and efficacy of multiple doses of the more than 100-year-old Bacillus Calmette-Guérin (BCG) vaccine against COVID-19. They also determine vaccine efficacy against other infectious diseases, which, if present, would suggest platform protection against new SARS-CoV-2 variants.