GlaxoSmithKline (GSK) has dosed the first participant in a Phase III clinical programme of its 5-in-1 meningitis vaccine candidate, MenABCWY.
The Phase III trials are designed to compare the vaccine candidate to the company’s licensed meningococcal vaccines, Bexsero and Menveo.
Menveo is a meningococcal group A, C, Y, and W-135 vaccine approved in 62 countries for active immunisation to prevent invasive meningococcal disease caused by Neisseria meningitides.
Meanwhile, Bexsero is a meningococcal group B vaccine licensed in more than 40 countries.
Since the vaccines’ initial authorisations in 2010 and 2013, respectively, the company has distributed more than 58 million doses of Menveo and 52 million doses of Bexsero.
GSK senior vice-president and Vaccines R&D head Emmanuel Hanon said: “Entering the final stage of clinical trials with our 5-in-1, MenABCWY vaccine candidate is a major step toward GSK’s goal of reducing meningococcal disease around the world.
“This vaccine candidate builds on the heritage of Bexsero and Menveo and we would like to thank all the scientific researchers, medical partners, advocates and families around the world who also hope for a successful outcome.”
The initial Phase III trials of MenABCWY will enroll 3,650 participants aged 10-25 across the US, Europe, Turkey and Australia.
The aim is to assess the safety, tolerability and immunogenicity of the 5-in-1 MenABCWY vaccine candidate compared to Bexsero and Menveo.
If successful in Phase III trials, MenABCWY is expected to reduce the number of injections needed to prevent Invasive Meningococcal Disease (IMD) in adolescents and young adults.
GSK added that the A, C, W, Y and B meningitis serogroups constitute almost all cases of IMD and a 5-in-1 combination vaccine is currently not available.
Though uncommon, IMD is considered a serious and unpredictable disease that can lead to death in as few as 24 hours.
In May this year, GSK announced plans to trial an investigational rheumatoid arthritis drug otilimab for the treatment of pneumonia caused by Covid-19.