GSK has announced positive results from the Phase III trial (NCT04502693) evaluating the safety, tolerability, and immunogenicity of its pentavalent MenABCWY vaccine candidate, administered as a two-dose schedule 6 months apart in healthy individuals 10 to 25 years of age. GSK’s MenABCWY vaccine candidate combines the antigenic components of its already licensed meningococcal vaccines: Bexsero (4CMenB) and Menveo (MenACWY-CRM).
The study achieved all primary endpoints, including non-inferiority of the candidate vaccine against all five serogroups of Neisseria meningitidis (A, B, C, W and Y) in terms of immune response and in comparison with the licensed meningococcal vaccines 4CMenB and MenACWY-CRM. Furthermore, the candidate vaccine was well tolerated, with a safety profile consistent with 4CMenB and MenACWY-CRM.
Invasive meningococcal disease (IMD), one of the leading causes of meningitis along with sepsis, is a rare but serious disease that can lead to life-threatening complications or even death, usually in previously healthy children and adolescents.1,2. Among those who contract meningococcal disease, one in ten will die, sometimes in as little as 24 hours, despite treatment1,2. One in five survivors suffer long-term consequences, including brain damage, amputations, hearing loss, and nervous system problems.1,2.
Five serogroups of Neisseria meningitidis (A, B, C, W and Y) represent almost all cases of EMI in most of the world2. At the moment, no licensed combination vaccine offers protection against all of the above serogroups in a single vaccine.2.
Tony Wood, GSK Chief Scientific Officer, said: “These statistically significant Phase III data are a very encouraging step in reducing the incidence of meningococcal disease. Our vaccine candidate marks another step in our global leadership in meningococcal vaccines and reinforces our commitment to innovation.”
GSK is working closely with Regulatory Authorities for the analysis of the Phase III dataset that will be presented in detail in a peer-reviewed scientific publication, as well as in upcoming scientific meetings.
About the Phase III MenABCWY Trial
The trial by GSK is a Phase III randomized, controlled, multinational, observer-blind clinical study to evaluate the safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate. This study is part of a comprehensive program to generate clinical evidence on the benefits of meningococcal immunization. The trial began in August 2020 and has enrolled approximately 3,650 participants between the ages of 10 and 25 from the US, Canada, the Czech Republic, Estonia, Finland, Turkey, and Australia.
The objective of the trial was to assess the safety profile of the MenABCWY candidate vaccine and to compare the immune responses of trial participants who received two doses of the MenABCWY candidate vaccine six months apart with the responses of those participants included in the control groups. who received the licensed GSK vaccines against 4CMenB and MenACWY-CRM.
About Bexsero (4CMenB)
4CMenB is currently licensed or has received regulatory approval in more than 50 countries, including the US and Europe, and is used in 12 national immunization programs worldwide for the prevention of IMD caused by serogroup B of Neisseria meningitidis. 4CMenB is the only serogroup B vaccine that has trials that have shown a reduction in EMI, including real-life vaccine effectiveness. Approvals vary by country. In Europe it is approved for use from two months of age or older.
About Menveo (MenACYW-CRM)
This vaccine protects against meningococcal serogroups A, C, Y, and W. Approved in more than 60 countries, including the US, since 2010, more than 72 million doses of this vaccine have been distributed worldwide. MenACWY-CRM is supported by extensive evidence for immunogenicity with a favorable safety profile (consistent with similar vaccines).
References:
1. Thompson MJ, Ninis N, Perera R, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397-403.
2. Meningitis. World Health Organization (WHO) [internet] 2021. [Accedido en marzo 2023] Available in:
Fuente: BERBES
