Patient dosing has started in a phase 3 clinical trial investigating a 5-in-1 meningitis vaccine candidate, according to the vaccine’s manufacturer.

“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,” Dr. Charles P. Andrews, MD, CPI, one of the study’s investigators and Director of Clinical Research at the Diagnostic Research Group in San Antonio, Texas, said. “The investigational vaccine has the potential to reduce the number of injections and thereby improve completion rates.”

The study will evaluate the safety, tolerability, and immunogenicity of the first 5-in-1 MenABCWY vaccine compared to licensed meningococcal vaccines, the meningococcal group B vaccine and the meningococcal groups A,C, Y, and W-135 vaccine. It will be conducted in individuals aged 10-25 years in the United States, Canada, Europe, Turkey and Australia. Approximately 3,650 participants will be enrolled.

While Invasive Meningococcal Disease (IMD) is uncommon, it is the leading cause of life-threatening bacterial meningitis in most of the industrialised world. About one in 10 who contract the disease will die, even with appropriate treatment, and around 20% of those who survive may suffer a major physical or neurological disability such as limb loss, hearing loss, or seizures. Five meningitis serogroups (A, C, W, Y and B) account for almost all cases of IMD. 

Adolescents and young adults are an at-risk group and have higher rates of meningitis due to close contact with one another, sharing drinks or utensils, kissing or coughing. In the U.S., the MenACWY immunization recommendation is for 11-to-12 years old with a booster at age 16. However, a study from 2018 showed that only 50.8% of older adolescents received the booster dose and the coverage rate of at least one meningitis B dose among 17-year-olds was 17.2%. 

“Entering the final stage of clinical trials with our 5-in-1, MenABCWY vaccine candidate is a major step toward GSK’s goal of reducing meningococcal disease around the world” Emmanuel Hanon, senior vice president and head of vaccines R&D for GSK, said. “This vaccine candidate builds on the heritage of Bexsero and Menveo and we would like to thank all the scientific researchers, medical partners, advocates and families around the world who also hope for a successful outcome.”