MenB-FHbp is a recombinant meningococcal serogroup B (MenB) vaccine composed of 2 factor H binding proteins (FHbps). Meningococcal vaccines targeting polysaccharide serogroup A, C, Y, and W capsules were licensed upon confirmation of bactericidal antibody induction after initial efficacy studies with serogroup A and C vaccines. Unlike meningococcal polysaccharide vaccines, wherein single strains demonstrated bactericidal antibodies per serogroup for each vaccine, MenB-FHbp required a more robust approach to demonstrate that bactericidal antibody induction could kill strains with diverse FHbp sequences. Serum bactericidal assays using human complement were developed for 14 MenB strains, representing breadth of meningococcal FHbp diversity of ~80% of circulating MenB strains. This work represents an innovative approach to license a non-toxin protein vaccine with 2 antigens representing a single virulence factor by an immune correlate, and uniquely demonstrates that such a vaccine provides coverage across bacterial strains by inducing broadly protective antibodies.

中文翻译：

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选择不同菌株以评估二价 FHbp 脑膜炎球菌 B 疫苗的广泛覆盖率。

MenB-FHbp 是一种重组脑膜炎球菌血清群 B (MenB) 疫苗，由 2 种 H 因子结合蛋白 (FHbps) 组成。在对血清组 A 和 C 疫苗进行初步功效研究后，在确认杀菌抗体诱导后，针对多糖血清组 A、C、Y 和 W 胶囊的脑膜炎球菌疫苗获得许可。与脑膜炎球菌多糖疫苗不同，其中单个菌株对每种疫苗的每个血清组都表现出杀菌抗体，MenB-FHbp 需要更强大的方法来证明杀菌抗体诱导可以杀死具有不同 FHbp 序列的菌株。为 14 种 MenB 菌株开发了使用人类补体的血清杀菌测定，代表了循环 MenB 菌株约 80% 的脑膜炎球菌 FHbp 多样性的广度。