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Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes.
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.
  • Faustman DL; Massachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA. Electronic address: dfaustman@mgh.harvard.edu.
  • Lee A; Massachusetts General Hospital, Boston, MA 02192, USA.
  • Hostetter ER; Massachusetts General Hospital, Boston, MA 02192, USA.
  • Aristarkhova A; Massachusetts General Hospital, Boston, MA 02192, USA.
  • Ng NC; Massachusetts General Hospital, Boston, MA 02192, USA.
  • Shpilsky GF; Massachusetts General Hospital, Boston, MA 02192, USA.
  • Tran L; Massachusetts General Hospital, Boston, MA 02192, USA.
  • Wolfe G; Massachusetts General Hospital, Boston, MA 02192, USA.
  • Takahashi H; Massachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
  • Dias HF; Massachusetts General Hospital, Boston, MA 02192, USA.
  • Braley J; Massachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
  • Zheng H; Massachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
  • Schoenfeld DA; Massachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
  • Kühtreiber WM; Massachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
Cell Rep Med ; 3(9): 100728, 2022 09 20.
Article in English | MEDLINE | ID: covidwho-1984241
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Communicable Diseases / Diabetes Mellitus, Type 1 / COVID-19 / Mycobacterium bovis Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Language: English Journal: Cell Rep Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Communicable Diseases / Diabetes Mellitus, Type 1 / COVID-19 / Mycobacterium bovis Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Language: English Journal: Cell Rep Med Year: 2022 Document Type: Article