MinervaX has initiated a Phase I clinical trial of its new GBS vaccine to assess the safety and immunogenicity in the older adult population with Group B Streptococcus (GBS).
The trial at Centre for Vaccinology (CEVAC) in Ghent, Belgium, will evaluate two doses of the GBS vaccine in older adults aged 55 to 75 years with and without underlying medical conditions.
Three doses of the GBS vaccine will be administered to older adults with comorbidities, due to a weak immune response.
MinervaX chief medical officer Lidia Oostvogels said: “Expanding the development of our GBS vaccine for use in an older adult population, including people with increased risk for GBS due to underlying co-morbidities, is a very important step for MinervaX in the battle against this pathogen.
“This builds on our efforts and experience to develop a product to provide protection to the most vulnerable populations, i.e., neonates in our maternal immunisation programme, and now older adults including those with certain co-morbid conditions.”
In addition, the company will evaluate the dose level of the GBS vaccine currently under progress for the safety and immune response in pregnant women. Subjects will be administered with 50μg of each fusion protein and a higher dose of 125μg.
Pregnant women enrolled across Denmark, the UK and South Africa were dosed with the GBS vaccine in the company’s second Phase IIb study.
CEVAC principal investigator professor Isabel Leroux-Roels said: “GBS is known to cause potentially life-threatening infections in older adults and currently there is no vaccine available to prevent this.”