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Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes
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) va...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9376308/ https://www.ncbi.nlm.nih.gov/pubmed/36027906 http://dx.doi.org/10.1016/j.xcrm.2022.100728 |
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author | 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. |
author_facet | 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. |
author_sort | Faustman, Denise L. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9376308 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-93763082022-08-15 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. Cell Rep Med Article 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. Elsevier 2022-08-15 /pmc/articles/PMC9376308/ /pubmed/36027906 http://dx.doi.org/10.1016/j.xcrm.2022.100728 Text en © 2022 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Article 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. Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes |
title | Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes |
title_full | Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes |
title_fullStr | Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes |
title_full_unstemmed | Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes |
title_short | Multiple BCG vaccinations for the prevention of COVID-19 and other infectious diseases in type 1 diabetes |
title_sort | multiple bcg vaccinations for the prevention of covid-19 and other infectious diseases in type 1 diabetes |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9376308/ https://www.ncbi.nlm.nih.gov/pubmed/36027906 http://dx.doi.org/10.1016/j.xcrm.2022.100728 |
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