Gsk’s MenABCWY combination vaccine candidate met all 11 primary endpoints of pivotal Phase 3 clinical trial and was well tolerated with a safety profile consistent with the same 2 licensed vaccines Bexsero (MenB) and Menveo (MenACWY). This was announced by the pharmaceutical company Gsk, in a note released today which highlights that, if approved, the 5-in-1 vaccine candidate – which combines the antigenic components of MenB and MenACWY – could provide the broadest coverage of the meningococcal serogroup and could lead to a simplified vaccination schedule.
In the phase 3 study (NCT04502693) evaluating the safety, tolerability and immunogenicity of the combined vaccine candidate MenABCWY, administered in two doses six months apart in healthy subjects aged between 10 and 25 years – explains the company note – all primary endpoints were met, including non-inferiority against all 5 Neisseria meningitides serogroups (A, B, C, W and Y) compared to licensed meningococcal vaccines in terms of immune response. Invasive meningococcal disease (IMD), a leading cause of meningitis and septicaemia, is an uncommon but serious disease that can cause life-threatening complications or even death, typically among previously healthy children and adolescents. Of those who get meningococcal disease, 1 in 10 dies, sometimes in just 24 hours, despite treatment. One in 5 survivors suffers long-term consequences, such as brain damage, amputations, hearing loss and nervous system problems.
Five serogroups of Neisseria meningitides (A, B, C, W and Y) are responsible for almost all cases of IMD in most of the world. To date – adds GSK – no authorized combination vaccine offers protection against these serogroups in a single vaccine. Currently, two separate vaccines requiring 4 injections are required to protect against all 5 serogroups in the United States. This immunization regimen, coupled with poor disease awareness, can lead to suboptimal immunization coverage rates, particularly for MenB, with an estimated coverage of only about 31% of adolescents in the United States.
“These statistically significant Phase 3 data are a very encouraging step toward reducing the incidence of meningococcal disease,” he says. Tony Wood, Chief Scientific Officer of GSK – In the United States, routine use of a 5-in-1 meningococcal vaccine with a two-dose regimen in adolescents 16 to 18 years of age shortly before the peak incidence of this disease could have a significant impact on health publish. Additionally, our 5-in-1 meningococcal vaccine candidate builds on our global leadership in meningococcal vaccines and our commitment to innovation.”