Results
Bacillus Calmette-Guérin, respiratory infections, SARS-CoV-2 infection
RESPIRATORY INFECTIONS, RTI, SARS-COV-2 INFECTION, RESPIRATORY TRACT INFECTION, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME
Patient characteristics are shown in Baseline characteristics of study participants.BCG, Bacillus Calmette-Guérin; CI, confidence interval; BMI, body mass index.In the first six months after vaccination, the cumulative incidence of SARS-CoV-2 infection was 0.014 (95% CI 0.005-0.031) in the placebo morning group and 0.034 (95% CI 0.018-0.056) in the BCG morning group (subdistribution hazard ratio [SDHR] 2.394, 95% CI 0.856-6.696) (Effect of morning and afternoon BCG vaccination compared to placebo in the first six months after vaccination.BCG, Bacillus Calmette-Guérin; RTI, Respiratory tract infection; SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2; CI, confidence interval; SDHR, subdistribution hazard ratio; IHR, interaction hazard ratio.Cumulative incidences and hazard ratios are reported with 95% confidence interval.Effect of morning and afternoon BCG vaccination compared to placebo in the period from six months to 12 months after vaccination.BCG, Bacillus Calmette-Guérin; RTI, Respiratory tract infection; SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2; CI, confidence interval; SDHR, subdistribution hazard ratio; IHR, interaction hazard ratio.Cumulative incidences and hazard ratios are reported with 95% confidence interval.Effect of morning and afternoon BCG vaccination compared to placebo in the full 12 months follow-up.BCG, Bacillus Calmette-Guérin; RTI, Respiratory tract infection; SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2; CI, confidence interval; SDHR, subdistribution hazard ratio; IHR, interaction hazard ratio.Cumulative incidences and hazard ratios are reported with 95% confidence interval.Due to the interventions of the COVID-19 pandemic, such as quarantine, isolation, and social distancing, the number of clinically relevant RTIs was much lower than SARS-CoV-2 infections. The SDHR was comparable in all time periods (In conclusion, neither participants vaccinated with BCG in the morning nor in the afternoon were protected against respiratory infections including SARS-CoV-2.