Evaluating the effect of BCG vaccination for non-specific protection from infection in senior citizens during the COVID-19 pandemic: A randomised clinical trial - 06/12/24
, Lise Gehrt a, b, c, Frederik Schaltz-Buchholzer a, d, Sören Möller e, f, Rikke Christiansen a, Lars Schellerup a, Lene Annette Norberg g, Tyra Grove Krause h, Sebastian Nielsen a, Mette Bliddal e, Peter Aaby a, d, Christine Stabell Benn a, b
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Summary |
Objectives |
The Bacillus Calmette-Guérin (BCG) vaccine may induce non-specific protection against unrelated infections. We tested the effect of BCG on the risk of infections among Danish senior citizens.
Methods |
Single-blinded randomised controlled trial including 1676 volunteers >65 years. Participants were randomised 1:1 to BCG or placebo and followed for 12 months. The primary outcome was acute infection leading to medical contact. Secondary outcomes were verified SARS-CoV-2 infection, self-reported respiratory symptoms, and all-cause hospitalisation. Data was analysed using Cox regression models, estimating hazard ratios (HR) with 95% confidence intervals (CI).
Results |
The incidence of acute infection was 52.1 and 58.2 per 100 person-years for BCG and placebo, respectively (HR=0.89, 95% CI=0.78–1.02). There was no effect of BCG on SARS-CoV-2 infections (0.97, 0.75–1.26) or all-cause hospitalisations (1.10, 0.80–1.50), but BCG was associated with more respiratory symptoms (1.21, 1.10–1.33). BCG reduced the incidence of acute infections among participants <75 years (0.82, 0.70–0.95) but not among those >75 years (1.14, 0.88–1.47). In participants, who were COVID-19 vaccinated before enrolment, BCG was associated with lower incidence of acute infections (0.65, 0.50–0.85).
Conclusion |
BCG did not reduce risk of acute infections among Danish seniors overall, but the effect was modified by age group and COVID-19 vaccination.
Trial registration |
ClinicalTrials.gov (NCT04542330) and EU Clinical Trials Register (EudraCT number 2020-003904-15). Full trial protocol is available at ClinicalTrials.gov.
Summary |
In a randomised clinical trial among Danish senior citizens, BCG vaccination did not reduce the overall risk of acute infection, but BCG was associated with reduced risk in participants <75 years and participants who received COVID-19 vaccines prior to enrolment.
Le texte complet de cet article est disponible en PDF.Highlights |
• | 1676 senior Danes were randomised 1:1 to BCG or placebo. |
• | BCG did not reduce the overall risk of acute infection for 12 months follow-up. |
• | BCG reduced the risk in those <75 years, and in COVID-19 vaccinated participants. |
• | BCG vaccinated participants reported more respiratory symptoms. |
Keywords : BCG vaccine, BCG revaccination, Non-specific effects of vaccines, Heterologous effects, COVID-19 pandemic, Randomised controlled trial, Senior citizens, Infectious diseases
Plan
Vol 89 - N° 6
Article 106319- décembre 2024 Retour au numéro
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