Summary
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.
【저자키워드】 COVID-19, Type 1 diabetes, Vaccine, Infectious diseases, BCG, Autoimmune, Bacillus Calmette-Guérin, phase 2/3 trial, host microbe interactions, hygiene hypothesis, randomized double blinded clinical trial, Clinicaltrials.gov: NCT02081326, 【초록키워드】 coronavirus disease, SARS-CoV-2, Efficacy, coronavirus, Diseases, Trial, severity, variant, Infection, Symptom, Infectious disease, diabetes, Randomized, Cohort, Patient, Pathogens, Placebo, incidence, platform, placebo-controlled, Safe, criteria, acute respiratory syndrome, double-blinded, subject, participant, systemic adverse events, cumulative, Bacillus, effective, event, prevention of COVID-19, PROTECT, enrolled, evaluate, meet, yielding, 【제목키워드】 Infectious disease, BCG vaccination, Multiple, prevention of COVID-19, diabete,