A randomised, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability and immunogenicity of three doses of an adjuvanted group B Streptococcus vaccine in older adults aged 55 to 75.
VaccineSep 18, 2026 (epub)
Lidia Oostvogels, Azhar Alhatemi, Simon De Gussem et al.
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In 30 seconds
This phase I randomized controlled trial assessed the safety, tolerability, and immunogenicity of an adjuvanted group B Streptococcus vaccine (GBS-AlpN) in 90 older adults aged 55 to 75, including those with obesity and/or type 2 diabetes. The study found that by Day 57, all but three participants who received GBS-AlpN had seroconverted for all four AlpN antigens.
Key findings
- By Day 57, all but three participants who received GBS-AlpN had seroconverted for all four AlpN antigens.
- Mild solicited local and systemic adverse events were reported in 53 healthy and 26 participants with obesity/type 2 diabetes.
- Seven serious adverse events were reported, all deemed unrelated to the vaccine.
Why it matters
The increasing burden of group B Streptococcus disease in older adults highlights the need for effective vaccination strategies. This study provides preliminary evidence supporting the immunogenicity of a potential vaccine in a vulnerable population.