MinervaX begins critical GBS vaccine trial

Group B streptococcus vaccine study will involve adult groups with and without underlying conditions

MinervaX – a biotechnology concentrating on a group B streptococcus (GBS) vaccine – has announced the first phase 1 clinical study among older adults. The research will unfold at the CEVAC (Centre for Vaccinology) in Belgium.

The study will examine the immunogenicity and safety of two doses levels when using the MinervaX novel GBS vaccine. This will be administered to in an older adult population group aged between 55 and 75 years of age. Some of these individuals will have underlying medical conditions and some will not.

Older adults – particularly those with comorbidities – often have a weaker immune response than younger populations and, therefore, up to three doses will be investigated during this trial.

Furthermore, the trial will investigate the safety and immune response to the specific dose level currently under development for use in pregnant women.

The condition GBS has a broad global unmet medical burden and can cause severe illness in people of all ages. It is normally associated with infection in pregnant women and newborns, however, invasive GBS disease in adults has been increasing over the last 40 years.

Older adult populations and adults with underlying chronic health conditions are at particular risk of invasive GBS disease. There are no approved vaccines currently available.

Lidia Oostvogels, chief medical officer at MinervaX, concluded: “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.”

Meanwhile, MinervaX has completed enrolment and dosing of its second phase 2 clinical trial of its novel GBS vaccine concerning pregnant women across Denmark, the UK and South Africa.

Professor Paul Heath, lead investigator of MinervaX’s phase 2b, reflected: “Streptococcus agalactiae is a common commensal in humans and approximately 25% of all adults will be colonised with GBS in the gastrointestinal or genitourinary tracts at any given time. We are aware of the considerable global burden of this invasive GBS disease in babies and pregnant women and of the urgent need for a vaccine to prevent this.”

He added: “More recently, we have become aware of the burden of GBS in non-pregnant adults, particularly in older adults, and those with underlying health conditions such as diabetes mellitus. There is no current mechanism for preventing GBS disease in this growing population, and there is a well-recognised morbidity and mortality.”