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GSK doses first patients in phase 3 meningitis vaccine trial

Clinical programme will test five-in-one vaccine candidate

GlaxoSmithKline (GSK) has announced that the first patients in a phase 3 clinical trial programme investigating its five-in-one meningitis vaccine candidate have been dosed.

According to GSK, the first phase 3 studies of the MenABCWY vaccine candidate will be conducted in individuals aged between ten and 25 years, across sites in the US, EU, Turkey and Australia.

The studies will aim to enrol 3,650 participants, and will evaluate the safety, tolerability and immunogenicity of MenABCWY compared to Bexsero and Menveo, GSK’s licensed meningitis vaccine products.

GSK’s five-in-one candidate targets five meningitis serogroups - A, C, W, Y and B - which account for nearly all cases of invasive meningococcal disease (IMD). Currently, there are no five-in-one combination vaccines for meningitis available anywhere in the world.

“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 P Andrews, study investigator 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,” he added.

Adolescents and young adults are more likely to contract meningitis due to their close contact with each other.

Although meningococcal disease is uncommon, studies have shown that between 2014-2017, the relative risk of contracting meningitis B was 3.5 to five times higher in university students aged 18-24 compared with peers not attending university.

“We’re excited to reach this important milestone in the development of a 5-in-1 MenABCWY vaccine. It offers the potential to help protect against all five vaccine-preventable serogroups with one combined product,” said Barbara Howe, vice president and director, vaccine medical and clinical US, GSK.

“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,” she added.

Article by
Lucy Parsons

19th August 2020

From: Research

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