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Activate: Randomized Clinical Trial of BCG Vaccination against Infection in the Elderly
Evangelos J Giamarellos-Bourboulis1, Maria Tsilika1, Simone Moorlag2
14(th) Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece.
Insights
Bacillus Calmette-Guérin (BCG) vaccination in the elderly significantly reduced new infections by 40% compared to placebo. This study shows BCG is safe and effective for protecting older adults against infections.
Area of Science:
- Immunology
- Vaccinology
- Geriatrics
Background:
- Bacillus Calmette-Guérin (BCG) vaccination is known to protect children against various infections beyond tuberculosis.
- The potential benefits of BCG vaccination in elderly populations for heterologous protection remain largely unexplored.
Purpose of the Study:
- To evaluate the efficacy and safety of BCG vaccination in elderly individuals to prevent new infections.
- To assess the impact of BCG on the incidence and time to first infection in a geriatric cohort.
Main Methods:
- A phase III, double-blind, randomized, placebo-controlled trial (ACTIVATE) involving 198 elderly patients.
- Participants received BCG or placebo at hospital discharge and were monitored for 12 months for new infections.
Main Results:
- BCG vaccination significantly increased the median time to the first infection (16 weeks vs. 11 weeks with placebo).
- The incidence of new infections was reduced by 40% in the BCG group (25.0%) compared to the placebo group (42.3%).
- Protection was most notable against respiratory tract infections of probable viral origin (HR 0.21, p=0.013); no significant difference in adverse effects was observed.
Conclusions:
- BCG vaccination is safe and demonstrates efficacy in protecting the elderly against new infections.
- Further research in larger studies is warranted to confirm these findings, particularly regarding protection against respiratory infections like COVID-19.
Abstract:
BCG vaccination in children protects against heterologous infections and improves survival independently of tuberculosis prevention. The phase III ACTIVATE trial assessed whether BCG has similar effects in the elderly. In this double-blind, randomized trial, elderly patients (n = 198) received BCG or placebo vaccine at hospital discharge and were followed for 12 months for new infections. At interim analysis, BCG vaccination significantly increased the time to first infection (median 16 weeks compared to 11 weeks after placebo). The incidence of new infections was 42.3% (95% CIs 31.9%-53.4%) after placebo vaccination and 25.0% (95% CIs 16.4%-36.1%) after BCG vaccination; most of the protection was against respiratory tract infections of probable viral origin (hazard ratio 0.21, p = 0.013). No difference in the frequency of adverse effects was found. Data show that BCG vaccination is safe and can protect the elderly against infections. Larger studies are needed to assess protection against respiratory infections, including COVID-19 (ClinicalTrials.gov NCT03296423).
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