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

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.