13价肺炎球菌结合疫苗在小鼠中的安全性及免疫原性评价

Safety and immunogenicity evaluation of 13-valent pneumococcal conjugate vaccine in mice

目的 评价13价肺炎球菌结合疫苗（13-valent penumococcal conjugate vaccine,PCV-13）在小鼠中的安全性及免疫原性.方法 将90只小鼠按简单随机法分为3组,分别免疫PCV-13、市售7价肺炎球菌结合疫苗（PCV-7）及生理盐水.于0、14、28 d分别进行3次皮下注射,观察免疫后小鼠的体重及状态变化至35 d.每组小鼠随机取10只在第14天进行眼眶采血,其余20只在第35天采血.采血后分离的血清于-40℃以下保存.用ELISA检测小鼠血清抗各型肺炎链球菌荚膜多糖IgG抗体水平.结果 PCV-13免疫小鼠的体重增加未受到抑制,且未观察到其他不良反应,疫苗的安全性良好.3针免疫后,PCV-13免疫小鼠的抗各型多糖抗体滴度都有上升,表明PCV-13具有良好的免疫原性.PCV-13与市售PCV-7对共同的7个血清型的免疫原性相同（t=0.004,P＞ 0.05）.结论 PCV-13在小鼠中具有良好的安全性和免疫原性,这为该疫苗的临床前研究提供了一定的理论依据.

Objective To evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine （PCV-13） in mice.Methods Ninety mice were simply randomized into 3 groups and immunized with PCV-13,commercial 7-valent pneumococcal conjugate vaccine （PCV-7）,and saline,respectively.Three subcutaneous injections were given on 0,14 and 28 d.Mice weight and state changes were observed for 35 days since first injection.Ten mice per group were randomly taken for eye blood sampling on 14 d,and the remaining 20 were sampled on 35 d.Sera were then separated and preserved under-40 ℃.ELISA was performed on serum samples to detect IgG antibody levels against each serotype pneumococcal capsular polysaccharide included in PCV-13.Results PCV-13 had no untoward effect on mice weight gain or other physical state,showing good safety.After 3 immunizations,antibody concentration against every serotype polysaccharide increased,suggesting potent immunogenicity of the vaccine.Compared with commercial PCV-7,PCV-13 presented similar immunogenicity toward all 7 mutual serotypes （t =0.004,P 〉0.05）.Conclusion The PCV-13 tested has good safety and immunogenicity in mice and this provides certain theoretical basis for the preclinical study of this vaccine.