GSK reports positive phase 3 results for five-in-one meningococcal vaccine candidate

GSK has reported positive top-line results from a phase 3 study of its five-in-one meningococcal vaccine candidate, MenABCWY, in healthy individuals aged ten to 25 years.

Invasive meningococcal disease (IMD) is an uncommon but serious illness that can cause life-threatening complications or even death, with the highest incidence occurring in children and adolescents.

Five Neisseria meningitides serogroups – A, B, C, W, and Y – account for nearly all IMD cases, but there are currently no licensed vaccines that offer simultaneous protection against all of them.

In the US, two separate vaccines needing four injections are required to protect against all five serogroups. This regimen, together with low awareness of the disease, can lead to poor immunisation rates, with an estimated coverage of only 31% of adolescents in the US.

It is hoped that GSK’s MenABCWY, which combines the antigenic components of its licensed Bexsero (MenB) and Menveo (MenACWY) meningococcal vaccines, would provide the widest possible protection against the disease and lead to higher vaccine uptake.

The phase 3 study evaluating the candidate met all of its primary endpoints, including a non-inferior immune response against all five serogroups in individuals receiving two doses of the MenABCWY vaccine candidate six months apart, compared to those receiving the Bexsero and Menveo regimen.

The vaccine was well tolerated, GSK said, with a safety profile consistent with Bexsero and Menveo.

The company also outlined that, in addition to the evaluation of MenABCWY, the study acted as a confirmatory trial for Bexsero, which has not yet received traditional approval in the US.

GSK’s chief scientific officer, Tony Wood, said: “This statistically significant phase 3 data is a very encouraging step toward reducing the incidence of meningococcal disease.

“In the US, routine use of a five-in-one 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 also announced positive phase 3 results last month for its respiratory syncytial virus (RSV) vaccine candidate in adults aged 60 years and older.

According to a statement from GSK, the company remains ‘on track’ to supply the vaccine candidate ahead of the 2023-24 northern hemisphere RSV season, pending regulatory decisions in the US, EU, Japan and other countries.