The early clinical development of a multicomponent vaccine against meningococcal serogroup B

The development of meningococcal serogroup B vaccines has been a worldwide public health priority based on continuing disease burden, combined with the scientific challenges associated with antigen identification. A new multicomponent vaccine, 4CMenB, is currently being evaluated for global licensure. The multicomponent strategy accounts for multiple surface antigens and, therefore, provides varied opportunities to induce bactericidal antibodies. 4CMenB contains four components: outer membrane vesicles from the New Zealand MenB outbreak strain, fHbp, NadA and NHBA. In early clinical studies protective antibody levels with acceptable tolerability outcomes were observed in persons who received 4CMenB starting at as young as 2 months of age. A meningococcal antigen-typing system has been developed to bridge clinical trial data with circulating strains. This article describes the early clinical development program and the rationale for Phase III study design and effectiveness evaluations.