GSK plc (LON/NYSE: GSK) has announced positive headline results from the phase III trial (NCT04502693) evaluating the safety, tolerability, and immunogenicity of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. GSK’s MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). All primary endpoints were met, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response. In addition, the vaccine candidate was well tolerated, with a safety profile consistent with Bexsero and Menveo.
· MenABCWY combination vaccine candidate met all 11 primary endpoints of the pivotal phase III clinical trial and was well tolerated with a safety profile consistent with Bexsero and Menveo
· The primary endpoint data demonstrated statistical non-inferiority compared to Bexsero and Menveo in individuals 10-25 years old, with the 5-in-1 vaccine candidate eliciting a clinically meaningful immune response
· If approved, this 5-in-1 vaccine candidate could provide the broadest meningococcal serogroup coverage and could lead to a simplified immunisation schedule
Invasive meningococcal disease (IMD), a major cause of meningitis and septicaemia, is an uncommon but serious illness that can cause life-threatening complications or even death, typically amongst previously healthy children and adolescents.1 Among those contracting meningococcal diseases, one in ten will die, sometimes in as little as 24 hours, despite treatment.2 One-in-five survivors suffers long-term consequences, such as brain damage, amputations, hearing loss and nervous system problems.1
Five Neisseria meningitides serogroups (A, B, C, W, and Y) account for nearly all IMD cases in most of the world.3 As yet, no licensed combination vaccine offers protection against these serogroups in a single vaccine. Currently, in the US, two separate vaccines needing four injections are required to protect against all five serogroups. This immunisation regimen, coupled with low awareness of the disease, can lead to sub-optimal immunisation coverage rates, particularly for MenB, with an estimated coverage of only approximately 31% of adolescents in the US.4
Tony Wood, Chief Scientific Officer at GSK, said: “These statistically significant phase III 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. In addition, our 5-in-1 meningococcal vaccine candidate builds on our global leadership in meningococcal vaccines and commitment to innovation.”
GSK is working closely with regulators to review the full phase III data set, including the supplemental Biologics License Application for Bexsero. This clinical trial was both the confirmatory trial for Bexsero and the phase III trial for MenABCWY. Detailed results from this phase III trial will be presented in a peer-reviewed publication and at upcoming scientific meetings.
1 ECDC, Factsheet about meningococcal diseases. Accessed March 2023.
2. Bing Wang et al., “Case fatality rates of invasive meningococcal disease by serogroup and age: A systematic review and meta-analysis”, in Vaccine, Volume 37, Issue 21, 9 May 2019, Pages 2768-2782. Accessed March 2023.
3 CDC. Meningococcal Disease Causes and How It Spreads | CDC. Accessed March 2023.
4 Pingali C, Yankey D, Elam-Evans LD, et al. National Vaccination Coverage Among Adolescents Aged 13-17 Years – National Immunization Survey-Teen, United States, 2021. MMWR Morb Mortal Wkly Rep 2022; 71:1101-1108.