ACYW135群脑膜炎球菌结合疫苗在小鼠模型中的安全性和免疫原性研究  

Safety and immunogenicity of groups A,C,Y and W135 meningococcal conjugate vaccine in the mouse model

作　　者：王婷婷[1] 李亚楠[2] 任涛[1] 郝倩[1] 张明华[1] 唐秀丽[1] 魏文进[1] 郑海发[1] 

机构地区：[1]北京民海生物科技有限公司研发部,102600 [2]中国食品药品检定研究院菌种室,北京100050

出　　处：《国际生物制品学杂志》2014年第4期157-160,共4页International Journal of Biologicals

基　　金：国家高科技研究发展计划（2012AA02A403）

摘　　要：目的 研究ACYW135群脑膜炎球菌结合疫苗（groups A,C,Y and W135 meningococcal conjugate vaccine,MCV）在小鼠中的安全性及免疫原性.方法 用4价MCV腹腔注射BALB/c小鼠,并于接种前及接种后7d称量小鼠体重,观察小鼠的体重变化.分别于0和14 d用4价MCV皮下免疫BALB/c小鼠,并分别于第1剂接种后7和21 d采血,用间接ELISA测定血清特异性抗体水平.采用成组t检验对实验结果进行统计分析.结果 在7d观察期间,所有小鼠的体重均增加,4价MCV接种小鼠与对照小鼠体重增加间的差异无统计学意义（t=1.988,P＞0.05）.100％4价MCV接种小鼠的抗各群多糖抗体阳转,且抗体水平随接种次数的增加而提高.4价MCV接种小鼠与相应的单价疫苗原液接种小鼠的血清抗A群（t=2.107,P＞0.05）、C群（t=1.343,P＞0.05）、Y群（t=1.648,P＞0.05）和W135群（t=0.556,P＞0.05）抗体水平间的差异无统计学意义.结论 4价MCV在小鼠中具有良好的安全性和免疫原性.Objective To study the safety and immunogenicity of a groups A,C,Y and W135 meningococcal conjugate vaccine （MCV） in mice.Methods BALB/c mice were injected intraperitoneally with the tetravalent MCV and body weights of mice were measured before and 7 days after injection.BALB/c mice were injected subcutaneously with the tetravalent MCV on day 0 and 14,and blood was collected 7 and 21 days after the first dose.Levels of serum antibodies against each polysaccharide were detected using indirect ELISA.The statistical analysis of the results was made by group t test.Results In the 7 days observation period,body weights of mice all increased,and weight gains had no significant difference between mice immunized with the tetravalent MCV and control mice （t=1.988,P〉0.05）.Serum conversion rates of antibodies against each polysaccharide were 100% in mice immunized with the tetravalent MCV,and levels of serum antibodies against each polysaccharide increased with the increase of injection times.Levels of serum antibodies against group A （t =2.107,P〉0.05）,group C （t=1.343,P〉0.05）,group Y （t=1.648,P〉0.05） and group W135 （t=0.556,P〉0.05） had no significant difference between mice immunized with the tetravalent MCV and relevant monovalent vaccine bulk.Conclusion The tetravalent MCV has good safety and immunogenicity in mice.

关 键 词：奈瑟球菌 脑膜炎 疫苗 结合 安全性 免疫原性 

分 类 号：R392[医药卫生—免疫学]