First patient dosing commences in GSK 5 in 1 meningitis jab
Patient dosing has begun in a Phase III clinical programme investigating GSK’s 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, Bexsero and Menveo.
Invasive Meningococcal Disease (IMD) is uncommon, with country-specific reported cases ranging from 0.1 to 2.4 cases per 100,000 population in 2017.
However, the disease can kill in as few as 24 hours and is the leading cause of life-threatening bacterial meningitis in most of the industrialised world, killing about one in 10 of those who contract the disease.
“Current FDA-approved meningitis vaccines help protect young persons who complete a four-injection regimen during adolescence but unfortunately, only a small percentage receive all four,” said Dr Charles Andrews, one of the study’s investigators and director of Clinical Research at the Diagnostic Research Group in San Antonio, Texas. “The investigational vaccine has the potential to reduce the number of injections and thereby improve completion rates.”
The initial Phase III studies will be conducted in individuals aged 10-25 years in the US, Europe, Turkey and Australia, enrolling around 3,650 participants.