GSK Launches Phase 3 Trial for 5-in-1 Meningitis Vaccine

August 25, 2020 - GSK recently announced that the first patients have been dosed in a Phase 3 clinical trial investigating its 5-in-1 meningitis vaccine candidate, MenABCWY.

The initial Phase 3 tiral will be enroll 3,650 individuals aged 10 to 25 years of age in the US, Canada, Europe, Turkey, and Australia and will evaluate the safety, tolerability, and immunogenicity of MenABCWY compared to licensed meningococcal vaccines, Bexsero and Menveo.

“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,” Emmanuel Hanon, senior vice president and head of vaccines R&D for GSK, said in the announcement.

“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 five meningitis serogroups, A, C, W, Y and B, account for nearly all cases of IMD. Yet, there is no 5-in-1 combination vaccine currently available, a GSK spokesperson said.

If the Phase 3 trial succeeds, helping protect adolescents and young adults from Invasive Meningococcal Disease (IMD) could require fewer injections.

“Current FDA-approved meningitis vaccines help protect young persons who complete a four-injection regimen during adolescence but unfortunately, only a small percentage receive all four,” said Charles P. Andrews, MD, CPI, one of the study’s investigators and director of clinical research at the diagnostic research group in Texas.

“The investigational vaccine has the potential to reduce the number of injections and thereby improve completion rates.”

Since GSK’s first approvals in 2010 and 2013, GSK has distributed over 58 million doses of Menveo and more than 52 million doses of Bexsero.

Currently, the US recommends MenACWY for individuals 11 to 12 years old with a booster at age 16

A 2018 study, however, showed that only 50.8 percent of older adolescents received the booster dose. And from 2011 to 2019, meningoccal B vaccine (MenB) was responsible for 100 percent of US college meningococcal disease outbreaks, including 13 campuses, 50 cases, and two deaths among nearly 253,000 students.

Country-specific reported cases for IMD ranged from 0.1 to 2.4 cases per 100,000 population in 2017, GSK said. Although uncommon, IMD can kill an infected individual in just 24 hours.

Adolescents and young adults have higher rates of meningitis due to close contact with each other. But between 2014 and 2017, the risk of contracting MenB as a college student was 3.5 to 5 times higher compared with those not attending college.

Back in 2016, experts said that MenABCWY has the potential to become the leader in market projected to be worth $1.8 billion by 2025.

“MenABCWY, effectively a co-formulation of GSK’s Menveo and Bexsero, could reduce the shot burden for patients, and will hold an advantage over other formulations in its combination of conjugated polysaccharides and purified protein-based antigens,” Mirco Junker, PhD, GlobalData analyst covering infectious diseases said in a press release.

“While polysaccharide vaccines can provide excellent protection in individuals against a specific set of serogroups, these vaccines are limited in their protective ability to these serogroups. By contrast, protein-based meningococcal vaccines, which include the MenB vaccine, can also protect against strains from other serogroups.”

MenABCWY vaccines in the US and European markets could potentially replace many of routinely administered meningococcal vaccines. It may became a possible replacement for the MenACWY booster currently recommended in the US.

“Currently, there are no products in the pipeline specifically designed to provide long-term protection against invasive meningococcal disease. However, several clinical trials, including for MenABCWY, are being conducted to further address this important unmet need in meningococcal disease prevention,” Junker concluded.