tetano
Editor, Senior Moderator
Cell Rep Med
. 2022 Aug 15;100728.
doi: 10.1016/j.xcrm.2022.100728. Online ahead of print.
Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes
Denise L Faustman[SUP] 1 [/SUP], Amanda Lee[SUP] 2 [/SUP], Emma R Hostetter[SUP] 2 [/SUP], Anna Aristarkhova[SUP] 2 [/SUP], Nathan C Ng[SUP] 2 [/SUP], Gabriella F Shpilsky[SUP] 2 [/SUP], Lisa Tran[SUP] 2 [/SUP], Grace Wolfe[SUP] 2 [/SUP], Hiroyuki Takahashi[SUP] 3 [/SUP], Hans F Dias[SUP] 2 [/SUP], Joan Braley[SUP] 3 [/SUP], Hui Zheng[SUP] 3 [/SUP], David A Schoenfeld[SUP] 3 [/SUP], Willem M Kühtreiber[SUP] 3 [/SUP]
Affiliations
Abstract
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.
Keywords: BCG; Bacillus Calmette-Guérin; COVID-19; Clinicaltrials.gov: NCT02081326; autoimmune; host microbe interactions; hygiene hypothesis; infectious diseases; phase 2/3 trial; randomized double blinded clinical trial; type 1 diabetes; vaccine.
. 2022 Aug 15;100728.
doi: 10.1016/j.xcrm.2022.100728. Online ahead of print.
Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes
Denise L Faustman[SUP] 1 [/SUP], Amanda Lee[SUP] 2 [/SUP], Emma R Hostetter[SUP] 2 [/SUP], Anna Aristarkhova[SUP] 2 [/SUP], Nathan C Ng[SUP] 2 [/SUP], Gabriella F Shpilsky[SUP] 2 [/SUP], Lisa Tran[SUP] 2 [/SUP], Grace Wolfe[SUP] 2 [/SUP], Hiroyuki Takahashi[SUP] 3 [/SUP], Hans F Dias[SUP] 2 [/SUP], Joan Braley[SUP] 3 [/SUP], Hui Zheng[SUP] 3 [/SUP], David A Schoenfeld[SUP] 3 [/SUP], Willem M Kühtreiber[SUP] 3 [/SUP]
Affiliations
- PMID: 36027906
- PMCID: PMC9376308
- DOI: 10.1016/j.xcrm.2022.100728
Abstract
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.
Keywords: BCG; Bacillus Calmette-Guérin; COVID-19; Clinicaltrials.gov: NCT02081326; autoimmune; host microbe interactions; hygiene hypothesis; infectious diseases; phase 2/3 trial; randomized double blinded clinical trial; type 1 diabetes; vaccine.