Preliminary trial results show the GSK five-in-one meningitis vaccine is immunologically effective against the most common strains, as the FDA decision date for Pfizer’s candidate looms.
Pictured: Syringe pulling vaccine from a vial / Adobe Stock, weyo
Friday, GlaxoSmithKline presented preliminary Phase III trial results on its next-generation meningococcal vaccine at the European Society for Paediatric Infectious Diseases annual meeting in Lisbon, showing that it is safe and effective in protecting against the disease caused by serogroups A, B, C, W and Y.
The strains in the company’s five-in-one meningitis vaccine account for 95% of those circulating in the U.S., according to GSK. The vaccine is designed as a single injection intended for healthy adolescents and adults 10–25 years old. It combines strains from Bexsero and Menveo, other GSK meningococcal vaccines currently licensed in the U.S.
Bexsero is a serogroup B meningococcal vaccine intended for infants and young children, while Menveo protects against serogroups A, C, W and Y in teens and adults. The Phase III data presented at the European Society for Paediatric Infectious Diseases (ESPID) meeting met all primary endpoints and demonstrated statistical non-inferiority compared to Bexsero and Menveo in healthy individuals 10–25 years old, reported GSK.
Bacterial meningitis is most common in infants, young children and adolescents. The disease is caused by a bacterium, and can spread through close contact with an infected person, such as through coughing or sneezing.
In addition to showing that the GSK next-generation meningococcal vaccine is safe and effective in protecting against meningococcal disease caused by serogroups A, B, C, W, and Y, GSK said the vaccine was well-tolerated by study participants and there were no serious adverse events reported.
The data from ESPID provides further support for the development of the GSK meningococcal ABCWY vaccine. The vaccine is currently in a Phase III clinical trial and could be submitted for regulatory approval in the coming years.
“The data from ESPID are very encouraging,” said Tony Wood, chief scientific officer at GSK. “The GSK meningococcal ABCWY vaccine has the potential to provide broad protection against meningococcal disease, which is a serious and potentially fatal infection. We are committed to working with regulatory authorities to bring this vaccine to patients as soon as possible.”
GSK’s data drop comes as the FDA’s October decision date for Pfizer’s candidate looms. In December 2022, Pfizer announced that the regulator accepted for review a BLA for its investigational pentavalent meningococcal vaccine candidate (MenABCWY) for the prevention of meningococcal disease caused by the most common serogroups in individuals 10 through 25 years of age.
Lisa Munger is a senior editor at BioSpace. You can reach her at lisa.munger@biospace.com. Follow her on LinkedIn or on Twitter at @lisagmunger.
