B群脑膜炎球菌疫苗免疫原性评价技术研究进展

Research progress on immunogenicity evaluation of serogroup B meningococcal vaccine

流行性脑脊髓膜炎(流脑)是一种病死率高且后遗症严重的急性呼吸道传染病,脑膜炎球菌疫苗是预防控制流脑的有效措施。目前,包括中国在内,B群流脑已成为全球主要流行的血清群。脑膜炎球菌ACYW等疫苗主要成分为荚膜多糖,而B群脑膜炎球菌疫苗主要成分为蛋白,有外膜囊泡(OMV)疫苗和重组蛋白疫苗两种。B群脑膜炎球菌疫苗免疫原性的评价方法包括人补体血清杀菌试验(hSBA)及脑膜炎球菌抗原分型系统(MATS)、脑膜炎球菌表面抗原表达试验(MEASURE)、脑膜炎球菌抗原分型系统(gMATS)和Bexsero疫苗抗原序列分型(BAST)等替代方法。疫苗免疫原性评价技术是疫苗研发和临床试验研究的基础,而我国目前尚无B群脑膜炎球菌疫苗。因此,本文就B群脑膜炎球菌疫苗免疫原性评价技术研究进展进行综述,以期为我国B群脑膜炎球菌疫苗研发和后期免疫原性评价及临床试验研究提供技术指导。

Epidemic cerebrospinal meningitis(meningococcal meningitis)is an acute respiratory infectious disease with high mortality and serious sequelae.Meningococcal vaccine is an effective measure to prevent and control meningococcal meningitis.At present,group B meningococcal meningitis has become the main prevalent serum group in the world,including China.Meningococcal ACYW and other vaccines are mainly composed of capsular polysaccharides,while the main component of group B meningococcal vaccine is protein,including outer membrane vesicles(OMV)and recombinant protein vaccine.The methods for evaluating the immunogenicity of group B meningococcal vaccine include hSBA and alternative methods such as meningococcal antigen typing system(MATS),flow cytometric meningococcal antigen surface expression assay(MEASURE),genetic meningococcal antigen typing system(gMATS)and bexsero antigen sequence type(BAST).The evaluation of vaccine immunogenicity is the basis of vaccine development and clinical trial research,However,at present,there is no group B meningococcal vaccine in China.Therefore,in this paper,the research progress of immunogenicity evaluation of group B meningococcal vaccine has been reviewed,in order to provide technical guidance for the research and development of group B meningococcal vaccine,immunogenicity evaluation and clinical trial research in China.