Abstract
In a recent study of our group with the acronym ACTIVATE, Bacillus Calmete-Guérin (BCG) vaccination reduced the occurrence of new infections compared to placebo vaccination in the elderly. Most benefit was found for respiratory infections. The ACTIVATE-2 study was launched to assess the efficacy of BCG vaccination against coronavirus disease 2019 (COVID-19). In this multicenter, double-blind trial, 301 volunteers aged 50 years or older were randomized (1:1) to be vaccinated with BCG or placebo. The trial end points were the incidence of COVID-19 and the presence of anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies, which were both evaluated through 6 months after study intervention. Results revealed 68% relative reduction of the risk to develop COVID-19, using clinical criteria or/and laboratory diagnosis, in the group of BCG vaccine recipients compared with placebo-vaccinated controls, during a 6-month follow-up (OR 0.32, 95% CI 0.13-0.79). In total, eight patients were in need of hospitalization for COVID-19: six in the placebo group and two in the BCG group. Three months after study intervention, positive anti-SARS-CoV-2 antibodies were noted in 1.3% of volunteers in the placebo group and in 4.7% of participants in BCG-vaccinated group. These data indicate that BCG vaccination confers some protection against possible COVID-19 among patients older than 50 years with comorbidities. BCG vaccination may be a promising approach against the COVID-19 pandemic.
Keywords: BCG; COVID-19; SARS-CoV-2; elderly vaccination; trained immunity.
【저자키워드】 COVID-19, SARS-CoV-2, BCG, trained immunity., elderly vaccination, 【초록키워드】 coronavirus disease, respiratory infections, antibodies, Efficacy, Vaccine, coronavirus, vaccination, Trial, Immunity, Hospitalization, COVID-19 pandemic, Infection, Comorbidities, Diagnosis, risk, Intervention, anti-SARS-CoV-2, Laboratory, Randomized, anti-SARS-CoV-2 antibody, Patient, Placebo, Follow-up, multicenter, reduction, BCG vaccination, acute respiratory syndrome, Older, 95% CI, participant, end point, clinical criteria, double-blind trial, positive, recipient, Bacillus, MOST, Volunteer, approach, controls, benefit, Occurrence, Result, develop, evaluated, eight, reduced, 1:1, incidence of COVID-19, patients older, the placebo group, 【제목키워드】 individual, Against,