Sabin IPV疫苗在版纳小耳猪体内的免疫原性及安全性研究

摘要

目的 评价 Sabin 株脊髓灰质炎灭活疫苗(inactivated poliovirus vaccine derived from Sabin strain, sIPV)在版纳小耳猪体内的免疫原性及安全性,为新型动物模型提供实验依据.方法 采用中国医学科学院医学生物学研究所已经上市的sIPV疫苗,设计sIPV肌肉免疫实验组与野毒株IPV(IPV derived from wild strain,wIPV)肌肉免疫对照组,以及生理盐水阴性对照组,按0、1、2 月基础免疫程序,接种版纳小耳猪,于免疫接种前及每剂免疫接种后第30天釆血,检测各组的血清中和抗体水平,评价免疫原性,并通过观察小耳猪的状态及体重情况,评价安全性.结果 版纳小耳猪3剂免疫后,sIPV试验组与wIPV对照组Ⅰ、Ⅱ、Ⅲ型抗体阳转率均达到了100%,各型中和抗体几何平均滴度(GMT)均远高于1∶8保护水平.版纳小耳猪接种疫苗后体重增加,结果表明sIPV疫苗在版纳小耳猪动物模型中具有良好的安全性.结论 sIPV疫苗在版纳小耳猪体内具有良好的免疫原性及安全性,版纳小耳猪可作为评价sIPV疫苗的新型实验动物模型.%Objective To evaluate the immunogenicity and safety of inactivated poliovirus vaccine derived from Sabin strain (sIPV) in Banna mini pigs, and to provide experimental evidence for the new animal model. Methods sIPV vaccines which are listed at Institute of Medical Biology at Chinese Academy of Medical Sciences were used in this study. The groups of intramuscular sIPV and the wild strain IPV injections (IPV derived from wild strain, wIPV) were designed, and the saline group was used as a negative control group. The Banna mini pigs in various groups were immunized at 0, 1 and 2 months. Blood samples were collected before immunization and on days 30 after each immunization. Levels of neutralizing antibodies were tested for evaluating immunogenicity. The safety was evaluated by observation of the status and weight of mini pigs. Results After the three dose immunization schedules in the Banna mini pigs, the seroconversion rates of type Ⅰ,Ⅱ and Ⅲ sIPV experimental groups and wIPV group were all up to 100%. The neutralizing antibody levels in all the three types were much higher than the protective titer 1: 8. The weight of mini pigs increased after vaccination. Conclusions The sIPV vaccine has good immunogenicity and safety in Banna mini pigs. Banna mini pigs could be a new animal model for evaluation of sIPV vaccine.