Positive results for 4CMenB (Novartis) vaccine against group B Meningococcal Disease

Results of a Phase IIb/III placebo-controlled clinical trial of 4CMenB, from Novartis, in which 1631 adolescents received the vaccine, suggest that is is a safe and efficacious vaccine for protection against group B meningococcal disease. Immunogenicity was assessed as serum bactericidal activity using human complement (hSBA), an established immunological correlate of protection against meningococcal disease, for three of the antigens (and for one antigen by ELISA) using three defined reference strains of serogroup B N meningitis. After two doses of 4CMenB, 99�100% of recipients had hSBA titres of 4 or more, indicative of protection against the test strains that were chosen to assess the individual contributions of the vaccine. The vaccine developed to target strain B includes four components targeting various parts of the bacterium. No vaccine-related serious adverse events were reported and no significant safety signals were identified. This research team and others have now completed studies into efficacy of this vaccine for adults, children, and adolescents, all yielding similar, positive results. The research was led by Professors Mar�a Elena Santolaya and Miguel L O'Ryan, University of Chile and published in The Lancet (January 18, 2012 DOI:10.1016/ S0140- 6736(11)61713-3) titled: "Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study."