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New Phase III data presented by Novartis Vaccines indicate that the investigational Multicomponent Meningococcal Serogroup B Vaccine (4CMenB) has the potential to be the first broad-coverage vaccine against the dynamic and deadly meningococcal B (MenB) disease. The data were presented at the International Pathogenic Neisseria Conference (IPNC) in Banff, Canada.
This trial involving more than 3,600 infants has met its primary end points. Results show that the large majority of those vaccinated with 4CMenB at the same time as other routine vaccines achieved a robust immune response against all vaccine MenB antigens. Additionally, results show that 4CMenB had an acceptable tolerability profile when co-administered with other routine infant vaccines, which supports potential use of the vaccine in the first year of life, when the medical need is greatest.
These new phase III data are part of a comprehensive clinical program led by Novartis to show that 4CMenB can be used across all age groups and can be either co-administered with other routine vaccines or as part of a flexible vaccination schedule. Additional Phase III trial results from ongoing studies are expected this autumn. The comprehensive data of more than 7,500 subjects is expected to be the basis for the planned filing in the EU by year end.
MenB is a sudden, aggressive illness that can lead to death within 24-48 hours of the first symptoms. The disease poses a significant burden to people around the world, especially infants, who are at highest risk for infection. MenB causes up to 80 percent of meningococcal disease cases in Europe, up to 55 percent of cases in Canada and 30 percent of cases in the US. MenB strains circulate worldwide, can mutate and may result in long-term regional outbreaks.
“The challenge with MenB is that there are thousands of circulating strains and developing a broadly protective vaccine has, until now, been difficult,” said Andrin Oswald, Head of Novartis Vaccines and Diagnostics Division. “These critical data highlight the promise of our innovative candidate 4CMenB vaccine in addressing the unmet public health need of MenB, the most common cause of bacterial meningitis for which there is no readily available global vaccine.”
The Novartis 4CMenB vaccine was developed using a pioneering approach known as “reverse vaccinology.” In contrast to conventional methods of producing vaccines, reverse vaccinology decodes the genetic makeup of MenB and finds the specific components that most typically cause infection. 4CMenB targets multiple components and is designed to provide an optimal immune response against the majority of MenB strains, while at the same time addressing the constantly changing nature of the bacteria.
“Meningitis B can be devastating for affected families and is a major concern for pediatricians who care for children with this serious illness. The disease can strike healthy children without warning and, in some countries, is the leading infectious cause of death in early life,” said Andrew Pollard FRCPCH PhD, Professor of Paediatric Infection and Immunity at the University of Oxford. “Many cases of meningitis are prevented today by the vaccines we give to our children, but the more complex meningitis B remains as a major threat to public health. The encouraging data presented on 4CMenB indicate the potential for additional protection to be provided by this new vaccine.”