GSK Announces Positive Pivotal Phase 3 Data for 5-in-1 Meningococcal Vaccine Candidate

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GSK announced positive results from a phase 3 trial (NCT04502693), which evaluated the immunogenicity, safety, and tolerability of its MenABCWY combination vaccine candidate.

The MenABCWY vaccine candidate combines the antigenic components of its meningococcal vaccines MenACWY (Menveo) and MenB (Bexsero). The vaccine candidate is administered as 2 doses given 6 months apart to healthy individuals aged 10 to 25 years.

“These statistically significant phase 3 data are a very encouraging step toward reducing the incidence of meningococcal disease. In the [United States], routine use of a 5-in-1 meningococcal vaccine with a 2-dose regimen in adolescents at 16 to 18 years of age, just before this disease’s incidence peak, could drive significant public health impact,” Tony Wood, PhD, chief scientific officer at GSK, said in a statement.

“In addition, our 5-in-1 meningococcal vaccine candidate builds on our global leadership in meningococcal vaccines and commitment to innovation,” he said.

The company conducted the trial starting in August 2020. There were approximately 3650 individuals, aged 10 to 25 years, enrolled in Australia, Canada, Czech Republic, Estonia, Finland, Turkey, and the United States.

The study was controlled, observer-blind, and randomized to evaluate the immunogenicity, safety, and tolerability of the MenACWY vaccine candidate. The study was part of a comprehensive program generated for clinical evidence on the benefits of meningococcal immunization.

Investigators reported that the study met all primary endpoints, including the non-inferiority of the vaccine candidate against all 5 Neisseria meningitides serogroups, A, B, C, W, and Y, compared with MenACWY and Men B for immune response.

Additionally, the vaccine candidate was generally well tolerated, with a safety profile consistent with the other 2 licensed vaccines. The objective of the trial was to assess the safety of the vaccine candidate for those who received it 6 months apart and those who received the 2 licensed vaccines.

GSK is working with regulators to review the full data set from the trial, which includes the supplemental biologics license application for MenB. The clinical trial served as both a confirmatory trial for MenB and a phase 3 trial for MenACWY.

Detailed findings will be presented in a peer-reviewed publication and at upcoming scientific meetings.

The 5 serogroups account for nearly all invasive meningococcal disease (IMD) cases, according to the statement.

There is no licensed combination vaccine that offers protection against all the serogroups in a single vaccine.

In the United States, individuals need 2 separate vaccines, requiring a total of 4 injections, to protect against all 5 serogroups.

The 4-injection regimen and a low awareness of the disease can lead to sub-optimal immunization coverage rates, specifically for MenB, according to investigators.

IMD, a major cause of meningitis and septicemia, is uncommon, but can cause life-threatening complications of even death, typically among healthy adolescents and children, according to the statement.

In the United States, MenACWY received regulatory approval for active immunization to prevent IMD, and MenB is licensed under the accelerated approval pathway to prevent IMD.

Reference

GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate. News release. GSK. March 14, 2023. Accessed March 14, 2023. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-pivotal-phase-iii-data-for-5-in-1-meningococcal-abcwy-vaccine-candidate/