Danish biotech MinervaX has launched the first Phase I clinical study in older adults of its novel Group B Streptococcus (GBS) vaccine, at CEVAC (Centre for Vaccinology) in Ghent, Belgium.
GBS is a global unmet medical burden and can cause serious illness in people of all ages, worldwide. It is normally associated with infection in pregnant women and new-born babies; however, invasive GBS disease in adults has been increasing over the last 40 years.
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. There is currently no vaccine available.
The clinical study will investigate the safety and immunogenicity of two dose levels on the MinervaX novel GBS vaccine in an older adult population from 55 to 75 years of age, with and without underlying medical conditions.
The company has also completed enrolment and dosing of its second Phase II clinical trial of the vaccine in pregnant women across Denmark, the UK and South Africa.
Prof Paul Heath, Director of the St George’s Vaccine Institute, London and Lead Investigator of MinervaX’s Phase IIb study across Denmark, the UK and South Africa, remarked: “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. The need for a vaccine for this group of people is therefore urgent and the commencement of GBS vaccine trials in this population is therefore an important and welcome development.”
