摘要目的:通过比较13价肺炎球菌多糖结合疫苗在BALB/c、KM、CD1小鼠品系体内的免疫应答，评价该疫苗的最佳小鼠免疫原性模型及此模型的最佳小鼠性别及免疫剂量。方法:将13价肺炎球菌多糖结合疫苗分别以每针次0.05、0.10、0.20、0.40 μg的剂量免疫3个品系小鼠，采用ELISA分析免疫应答差异以评价最佳小鼠模型；比较4个剂量在最佳小鼠模型中的雌雄小鼠应答差异以评价最佳小鼠性别；比较4个剂量免疫最佳性别的最佳小鼠模型以评价最佳免疫剂量。结果:3个品系中，多数血清型在CD1小鼠中免疫应答值最高，KM小鼠应答最弱。在CD1小鼠品系中剂量与免疫应答之间有明显量效关系。4个剂量免疫CD1雌雄小鼠，0.05 μg剂量时免疫应答值均较低，在0.10、0.20、0.40 μg剂量时，几乎所有血清型在雌性小鼠中产生的免疫应答值均高于雄性小鼠。4个剂量免疫CD1雌性小鼠，除3、9V、19F、23F型外，其余血清型在0.20 μg剂量产生的免疫应答值均明显高于其他3个剂量。结论:评价13价肺炎球菌多糖结合疫苗免疫原性的最佳小鼠模型为雌性CD1小鼠，最佳免疫剂量为0.20 μg。

abstractsObjective:To evaluate the optimal mouse immunogenicity model of 13-valent pneumococcal polysaccharide conjugate vaccine and the optimal mouse gender and immune dose by comparing the immune response in BALB/c, KM, and CD1 mice.Methods:The 13-valent pneumococcal polysaccharide conjugate vaccine was used to immunize 3 strains of mice with doses of 0.05, 0.10, 0.20 and 0.40 μg, respectively. ELISA was used to analyze the immune responses to evaluate the optimal mouse model. Response of male and female mice of the optimal model immunized with 4 different doses was compared to evaluate the optimal mouse gender. Response of optimal mouse model of optimal gender immunized with 4 different doses was compared to evaluate the optimal immune dose.Results:The immune response values of most serotypes were the highest in CD1 mice, and the weakest in KM mice. There was a significant dose-response relationship in CD1 mice. Immune responses of both male and female mice were low at 0.05 μg dose. At doses of 0.10, 0.20, and 0.40 μg, almost all serotypes showed higher immune responses in female mice than in male mice. The immune response of CD1 female mice immunized with 0.20 μg was the highset in most serotypes except 3, 9V, 19F, and 23F.Conclusion:CD1 female mouse is the optimal immunogenicity evaluation model for 13-valent pneumococcal polysaccharide conjugate vaccine, and 0.20 μg is the optimal immunization dose.