ACYWl35群脑膜炎球菌多糖结合疫苗的研制  

Development of groups ACYW135 meningococcal polysaccharide conjugate vaccine

作　　者：张明华[1] 任涛[1] 曹欣[1] 唐秀丽[1] 韩菲[1] 王婷婷[1] 胡鹏[1] 张美香[1] 郝倩[1] 何佳琦[1] 郑海发[1] 魏文进[1] 

机构地区：[1]北京民海生物科技有限公司研发部,102600

出　　处：《国际生物制品学杂志》2013年第2期61-65,共5页International Journal of Biologicals

基　　金：基金项目：国家高科技研究发展计划（2012AA02A403）

摘　　要：目的制备安全有效的四价脑膜炎球菌多糖结合疫苗。方法用溴化氰分别将A、C、Y、W135群脑膜炎球菌多糖活化，以己二酸二酰肼作为连接剂，碳化二亚胺作为偶联剂，先制备单价A、C、Y、W135群脑膜炎球菌多糖-白喉类毒素（diphtheriatoxoid，DT）结合疫苗，再配比制成ACYWl35群脑膜炎球菌多糖结合疫苗（groups ACYWl35 meningococcal polysaccharide—DT conjugatevaccine，ACYWl35一DT）。以ACYWl35-DT免疫小鼠，用间接ELISA检测小鼠血清抗各多糖抗体，采用f检验对检测结果进行统计学分析。结果制备的ACYWl35-DT的各项指标均达到质控标准，而且ACYWl35-DT具有良好的安全性和免疫原性，ACYWl35-DT免疫小鼠的抗A群多糖-IgG（f=24．487，P〈0．01）、抗C群多糖-IgG（f=17．056，P〈0．01）、抗Y群多糖-IgG（t=26．213，P〈0．01）和抗W135群多糖-IgG（t=17．392，P〈0．01）水平明显高于四价脑膜炎球菌多糖疫苗免疫小鼠。结论采用此项技术可成功制备ACYWl35-DT。Objective To prepare a safe and effective quadrivalent meningococcal polysaccharide conjugate vaccine. Methods Groups A, C, Y and W135 meningococcal polysaccharide were activated by cyanogen bromide, respectively. With 1,6-adipic acid dihydrazide as linking agent, monovalent meningococcal polysaceharide conjugate vaccines were prepared by carbodiimide-mediated coupling of meningococcal polysaccharide with carrier protein diphtheria toxoid （DT）, then groups ACYW135 meningococcal polysaccharide-DT conjugate vaccine （ACYW135-DT） was prepared by mixing each monovalent meningococcal polysaccharide conjugate vaccine in a certain proportion. Mice were immunized with ACYW135-DT, and antibodies to each polysaccharide were detected by indirect ELISA. The statistical analysis of the results were made by t test. Results Each index of the prepared ACYW135-DT achieved quality control standard. ACYW135-DT had a good safety and immunogenicity. The levels of IgG antibodies to group A （t = 24. 487, P〈0.01）, group C （t = 17. 056, P 〈0. 01）, group Y （t =26. 213, P 〈0. 01） and group W135 （t = 17. 392, P 〈0.01 ） polysaccharides in mice immunized with ACYW135-DT were significantly higher than those in mice immunized quadrivalent meningococcal polysaccharide vaccine. Conclusion ACYW135-DT is successfully prepared with this technology.

关 键 词：奈瑟球菌 脑膜炎 疫苗 结合 多糖类 细菌 白喉类毒素 

分 类 号：R392[医药卫生—免疫学]