Harris Shannon L, Tan Cuiwen, Perez John, Radley David, Jansen Kathrin U, Anderson Annaliesa S, Jones Thomas R
Pfizer Vaccine Research and Development, Pearl River, NY USA.
2Pfizer Vaccine Research and Development, Collegeville, PA USA.
NPJ Vaccines. 2020 Jan 29;5(1):8. doi: 10.1038/s41541-019-0154-0. eCollection 2020.
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.
B群脑膜炎球菌因子H结合蛋白（MenB-FHbp）是一种重组B群脑膜炎球菌（MenB）疫苗，由2种因子H结合蛋白（FHbps）组成。针对A、C、Y和W多糖荚膜群的脑膜炎球菌疫苗在A群和C群疫苗初步疗效研究证实诱导杀菌抗体后获得许可。与脑膜炎球菌多糖疫苗不同，在脑膜炎球菌多糖疫苗中，每种疫苗的每个血清群都有单一菌株可诱导杀菌抗体，而MenB-FHbp需要采用更有力的方法来证明诱导杀菌抗体能够杀死具有不同FHbp序列的菌株。针对14株B群脑膜炎球菌开发了使用人补体的血清杀菌试验，这些菌株代表了约80%的循环B群脑膜炎球菌菌株的FHbp多样性广度。这项工作代表了一种创新方法，通过免疫相关指标为一种具有2种代表单一毒力因子的抗原的非毒素蛋白疫苗颁发许可，并且独特地证明了这种疫苗通过诱导具有广泛保护作用的抗体来提供针对不同菌株的覆盖范围。
