GSK’s five-in-one meningococcal vaccine candidate has shown promising results in a phase 3 trial involving healthy individuals aged ten to 25 years.
Preliminary results for the MenABCWY candidate were presented by the company at the European Society for Paediatric Infectious Diseases congress in Lisbon, Portugal.
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 approved 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.
It is hoped that GSK’s MenABCWY, which combines the antigenic components of its approved 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.
In a separate confirmatory arm of the trial, the candidate showed immunological effectiveness against a panel of 110 diverse MenB invasive strains, which account for 95% of strains circulating in the US.
GSK’s chief scientific officer, Tony Wood, said: “This preliminary data further unlocks 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.”
The company said it is now “working closely” with regulatory agencies to review the full phase 3 results and prepare filings. This includes a supplemental application for Bexsero, which has not yet received traditional approval in the US.