GSK Announces First Participant Vaccinated in Phase 3 Clinical Trial of Its 5-in-1 Meningococcal Vaccine Candidate MenABCWY

August 20, 2020 /BioValleyBIOON/ --GlaxoSmithKline(GSK) recently announced that the first participant in its Phase III clinical program for the investigational pentavalent meningococcal vaccine (MenABCWY) has been vaccinated. The program aims to compare MenABCWY with the company’s two licensed meningococcal vaccines, Bexsero and Menveo.

The first immunization of the first subject in the Phase III trial with MenABCWY marks a significant milestone in GSK’s leadership in meningitis vaccine development. Since its initial approvals in 2010 and 2013, GSK has distributed more than 58 million doses of Menveo (meningococcal groups A, C, Y, W-135 vaccine) and over 52 million doses of Bexsero (group B meningococcal vaccine).

Emmanuel Hanon, Senior Vice President and Head of Vaccine R&D at GSK, stated, “The pentavalent MenABCWY candidate vaccine entering late-stage clinical trials marks a significant step forward in our goal to reduce meningococcal disease worldwide. This candidate vaccine builds on the established legacy of Bexsero and Menveo. We extend our gratitude to researchers, healthcare partners, advocates, and families around the world who are committed to achieving successful outcomes in this research.”

The first Phase III study of this project (NCT04502693) will enroll 3,650 participants aged 10–25 years in the United States, Europe, Turkey, and Australia, with the aim of evaluating the safety, tolerability, and immunogenicity of MenABCWY compared to two commercially available meningococcal vaccines, Bexsero and Menveo, in adolescents and young adults.

If GSK’s pentavalent meningococcal vaccine MenABCWY in this Phase IIIClinical TrialIf successful, it will help protect adolescents and young adults from invasive meningococcal disease (IMD) with fewer immunization injections. Five meningococcal serogroups (A, C, W, Y, B) account for nearly all IMD cases, but no pentavalent combination vaccine is currently available.

One of the study investigators, San Antonio, TexasDiagnosisCharles P. Andrews, Director of Clinical Research at the study group, stated: “Currently in the United StatesFDA“Approved meningitis vaccines can help protect young people who complete the four-dose immunization schedule during adolescence, but unfortunately, only a small proportion complete all four doses. The pentavalent MenABCWY meningitis vaccine has the potential to reduce the number of injections, thereby improving immunization completion rates.”

Invasive Meningococcal Disease (Image source: gskpro.com)

In the United States, the immunization recommendation for the MenACWY vaccine is to administer a booster dose to adolescents at age 16, following the initial vaccination at ages 11–12. However, a 2018 study showed that only 50.8% of older adolescents received the booster dose. The MenB vaccine is recommended for adolescents aged 16–23 years (preferably 16–18 years) based on “shared clinical decision-making” between healthcare providers and parents. Nevertheless, the coverage rate for at least one dose of the MenB vaccine among 17-year-olds was only 17.2%. From 2011 to March 2019, MenB was responsible for 100% of meningococcal disease outbreaks on U.S. college campuses, affecting approximately 253,000 students in the high-risk population, with 50 cases and 2 deaths reported across 13 campuses.

Dr. Barbara Howe, Vice President and Director of Clinical Development and Medical Affairs at GSK Vaccines, stated, “We are pleased to reach this important milestone in the development of our 5-in-1 MenABCWY vaccine, which offers the potential to help prevent all five vaccine-preventable serogroups with a single product. This can reduce the complexity and potential confusion associated with requiring two different types of vaccines, while also reducing the number of injections needed.” (Bioon.com)

Original Source: GSK announces first participant vaccinated in phase 3 clinical trials of its 5-in-1, meningitis ABCWY vaccine candidate