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Pivotal data is presented at ESPID confirming effectiveness of the 5-in-1 meningococcal ABCWY vaccine candidate, with demonstrated coverage against a panel of 110 MenB strains- GSK

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Published:15th May 2023

GSK plc presented preliminary positive results from the phase III trial (NCT04502693) evaluating the immunological vaccine effectiveness and safety of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. The preliminary data were disclosed at the 41st Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) in Lisbon, Portugal.

 

The vaccine candidate demonstrated non-inferiority in primary endpoints for five Neisseria meningitidis serogroups (A, B, C, W, and Y) compared to two doses of Bexsero (meningococcal group B vaccine) and one dose of Menveo (meningococcal group A, C, W-135, and Y conjugate vaccine) in 10–25-year-olds. In addition, the vaccine candidate was generally well tolerated, with a safety profile consistent with Bexsero and Menveo. In a separate confirmatory arm of this phase III trial, the MenABCWY vaccine candidate showed immunological effectiveness against a panel of 110 diverse meningococcal serogroup B (MenB) invasive strains, which account for 95% of strains circulating in the US.

Tony Wood, Chief Scientific Officer at GSK, said: “These preliminary data further unlock the potential of our MenABCWY vaccine candidate in providing protection against invasive meningococcal disease caused by serogroups A, B, C, W and Y. It’s particularly encouraging to see the breadth of coverage against the broadest panel of circulating MenB strains to date, as we know MenB is the most common cause of meningococcal disease in the US with the lowest immunisation rate.”

Five Neisseria meningitidis serogroups (A, B, C, W, and Y) account for nearly all invasive meningococcal disease (IMD) cases in most of the world. Meningitis B is the most common serogroup in the US and accounts for more than half of meningococcal disease cases among 16–20-year-olds. Currently immunisation coverage rates for Men B are estimated at approximately 31% of adolescents in the US. GSK’s MenABCWY vaccine candidate combines the antigenic components of licensed meningococcal vaccines, Bexsero and Menveo. The aim of combining two effective vaccines into one is to help simplify immunisation schedules, which can in turn increase vaccination coverage and help reduce the overall burden of disease.

GSK is working closely with regulatory agencies to review the full phase III data set, including the supplemental Biologics License Application for Bexsero for confirmation of full licensure under the Accelerated Approval pathway. Detailed results will be submitted for publication in a peer-reviewed scientific journal later this year.

About the MenABCWY phase III trial The trial conducted by GSK is a phase III randomised, controlled, observer-blind, multi-country trial to evaluate the safety, tolerability, and immunogenicity of GSK’s MenABCWY vaccine candidate. It is part of a comprehensive programme to generate clinical evidence on the benefits of meningococcal immunisation. The trial started in August 2020, and approximately 3,650 participants aged 10-25 were enrolled in the US, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia.

The objective of the trial was to assess the safety profile of the MenABCWY vaccine candidate, to assess the immunological vaccine effectiveness against a panel of 110 MenB strains, and to compare the immune responses of the trial’s participants who received two doses of the MenABCWY vaccine candidate six months apart to the responses of those in the control groups who received GSK’s licensed vaccines, Bexsero (MenB) and one dose of Menveo (MenACWY). There are a total of 11 primary endpoints for the trial, five for MenABCWY and six for Bexsero. Bexsero is used as the comparator for the MenB immune responses induced by the MenABCWY vaccine in the trial, which is both the phase III trial for MenABCWY and confirmatory trial for Bexsero in the US.

Condition: Meningococcal Disease
Type: drug

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