MinervaX announced in April 2023 that it is beginning a Phase I clinical study of its novel Group B Streptococcus (GBS) vaccine in older adults. The trial will take place at the Centre for Vaccinology (CEVAC) in Belgium. This effort follows Pfizer’s attempt at a vaccine, which was awarded BTD in September 2022.
An unmet need
In March 2023 we observed that a study into the benefits of an equitably priced vaccine for GBS would have “potential to save tens of thousands of lives” and be a “cost-effective investment”. The April press release from MinervaX describes GBS as a “global unmet medical burden” that affects people of all ages across the world. Although often identified in “pregnant women and new-born babies”, GBS in adults has increased over recent decades.
“The older adult population (>65 years of age) and adults with underlying chronic health conditions (diabetes mellitus, cancer, immune suppression, obesity) are at particular risk of invasive GBS disease.”
The clinical study
The study investigates the safety and immunogenicity of the GBS vaccine in a population ranging from 55 to 75 years old, with and without underlying medical conditions. It will investigate the safety and immune response for two dose levels. The first is under development for use in pregnant patients, and a higher dose will be compared.
The statement suggests that older adults, and those with comorbidities, “often mount a less strong immune response than a younger population”. Thus, up to three doses will be investigated in the trial.
A vaccine for vulnerable populations
Lidia Oostvogels, Chief Medical Officer at MinervaX, is glad to expand the development of the vaccine to an older adult population, including people with increased risk for GBS. She described it as 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.”
Professor Isabel Leroux-Roels is Principal Investigator at CEVAC and commented on the team’s happiness at the opportunity to “contribute to the development of this vaccine for this high-risk population”.
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