Meningococcal ABCWY Vaccine Candidate Meets All Endpoints in Pivotal Phase 3 Trial

The meningococcal MenABCWY combination vaccine candidate in development by GSK met all 11 primary endpoints of the pivotal phase 3 clinical trial assessing the vaccine’s safety, tolerability, and immunogenicity.

The findings, announced by GSK on March 14, include data on the primary endpoint that demonstrated the statistical noninferiority of the shot compared to current GSK meningococcal vaccines Bexsero and Menveo, according to the company.

The vaccine was administered to healthy individuals between the ages of 10- and 25-years in 2 doses scheduled 6 months apart.

The “5-in-1” vaccine, if approved by the FDA, could provide the broadest meningococcal serogroup coverage and allow simplification of the current meningococcal immunization schedule, according to GSK.

“These statistically significant phase 3 data are a very encouraging step toward reducing the incidence of meningococcal disease. In the US, routine use of a 5-in-1 meningococcal vaccine with a two-dose regimen in adolescents at 16 to 18 years of age, just before this disease’s incidence peak, could drive significant public health impact,” GSK Chief Scientific Officer Tony Wood, PhD, said in the announcement.

The GSK MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). With regard to immune response, the study met all primary endpoints, including noninferiority of the vaccine candidate for all 5 Neisseria meningitides serogroups (A, B, C, W, and Y) when compared to Bexsero and Menveo.

The MenABCWY candidate was well tolerated in study participants with a safety profile deemed consistent with those of Bexsero and Menveo, GSK said.

The phase 3 randomized, controlled, observer-blind, multicountry trial to evaluate the safety, tolerability, and immunogenicity of GSK’s MenABCWY vaccine candidate was initiated in August 2020 and enrolled approximately 3650 participants aged 10 to 25 years in the US, Canada, the Czech Republic, Estonia, Finland, Turkey, and Australia.

This clinical trial was both the confirmatory trial for Bexsero and the phase 3 trial for MenABCWY. GSK is working closely with regulators to review the full phase 3 data set, including the supplemental Biologics License Application for Bexsero.

GSK notes that results of the phase 3 trial will be published in a peer-reviewed journal and also presented at upcoming scientific meetings.