Article ; Online: Bacillus Calmette-Guérin vaccine for prevention of COVID-19 and other respiratory tract infections in older adults with comorbidities: a randomized controlled trial.
2023 Volume 29, Issue 6, Page(s) 781–788
Abstract: Objectives: To test whether Bacillus Calmette-Guérin (BCG) vaccination would reduce the incidence of COVID-19 and other respiratory tract infections (RTIs) in older adults with one or more comorbidities.: Methods: Community-dwelling adults aged 60 ... ...
Abstract | Objectives: To test whether Bacillus Calmette-Guérin (BCG) vaccination would reduce the incidence of COVID-19 and other respiratory tract infections (RTIs) in older adults with one or more comorbidities. Methods: Community-dwelling adults aged 60 years or older with one or more underlying comorbidities and no contraindications to BCG vaccination were randomized 1:1 to BCG or placebo vaccination and followed for 6 months. The primary endpoint was a self-reported, test-confirmed COVID-19 incidence. Secondary endpoints included COVID-19 hospital admissions and clinically relevant RTIs (i.e. RTIs including but not limited to COVID-19 requiring medical intervention). COVID-19 and clinically relevant RTI episodes were adjudicated. Incidences were compared using Fine-Gray regression, accounting for competing events. Results: A total of 6112 participants with a median age of 69 years (interquartile range, 65-74) and median of 2 (interquartile range, 1-3) comorbidities were randomized to BCG (n = 3058) or placebo (n = 3054) vaccination. COVID-19 infections were reported by 129 BCG recipients compared to 115 placebo recipients [hazard ratio (HR), 1.12; 95% CI, 0.87-1.44]. COVID-19-related hospitalization occurred in 18 BCG and 21 placebo recipients (HR, 0.86; 95% CI, 0.46-1.61). During the study period, 13 BCG recipients died compared with 18 placebo recipients (HR, 0.71; 95% CI, 0.35-1.43), of which 11 deaths (35%) were COVID-19-related: six in the placebo group and five in the BCG group. Clinically relevant RTI was reported by 66 BCG and 72 placebo recipients (HR, 0.92; 95% CI, 0.66-1.28). Discussion: BCG vaccination does not protect older adults with comorbidities against COVID-19, COVID-19 hospitalization, or clinically relevant RTIs. |
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MeSH term(s) | Humans ; Aged ; COVID-19/epidemiology ; COVID-19/prevention & control ; BCG Vaccine ; Vaccination ; Hospitalization ; Incidence |
Chemical Substances | BCG Vaccine |
Language | English |
Publishing date | 2023-02-02 |
Publishing country | England |
Document type | Randomized Controlled Trial ; Journal Article |
ZDB-ID | 1328418-6 |
ISSN | 1469-0691 ; 1470-9465 ; 1198-743X |
ISSN (online) | 1469-0691 |
ISSN | 1470-9465 ; 1198-743X |
DOI | 10.1016/j.cmi.2023.01.019 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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