First patients dosed in GSK’s Phase III meningitis vaccine trial
The trial will assess the safety, tolerability and immunogenicity of the five-in-one MenABCWY vaccine in participants aged 10 to 25.
GSK (GlaxoSmithKline) reports it has dosed the first patients enrolled on the Phase III trial testing its five-in-one meningitis vaccine candidate.
The MenABCWY vaccine will be administered to participants aged 10 to 25 at sites in the US, EU, Turkey and Australia as part of the multicentred trial. The study will evaluate the safety, tolerability and immunogenicity of MenABCWY compared to comparable meningitis vaccine products licenced to the company by Bexsero and Menveo and aims to enrol 3,650 individuals.
The novel candidate targets five meningitis serogroups – A, C, W, Y and B – which account for nearly all cases of invasive meningococcal disease (IMD). If successful, it would be the first five-in-one combination vaccine for meningitis available anywhere in the world.
“Current [US Food and Drug Administration] 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, study investigator and director of clinical research at the Diagnostic Research Group in San Antonio, Texas, US. “The investigational vaccine has the potential to reduce the number of injections and thereby improve completion rates.”
According to the enterprise, adolescents and young adults are more likely to contract meningitis due to their close contact with each other. They added that, although meningococcal disease is uncommon, studies have shown that the relative risk of contracting meningitis B was up to five times higher in university students aged 18-24 compared with peers not attending university.
“We are excited to reach this important milestone in the development of a five-in-one MenABCWY vaccine. It offers the potential to help protect against all five vaccine-preventable serogroups with one combined product… This could reduce complexity and the potential confusion of needing two different types of vaccines, along with the added benefit of fewer injections for each patient,” said Barbara Howe, vice president and director, vaccine medical and clinical US, GSK.
