无针皮内免疫接种Sabin IPV疫苗的安全性及免疫原性研究  

Safety and Immunogenicity of Sabin Inactivated Poliovirus Vaccine with Intradermal Immunization by a Needle-Free Injector

作　　者：朱文勇[1] 蔡玮[1] 王东宝[1] 杨伟[1] 孙溢 胡文著 宋绍辉[1] 李卫东[1] 廖国阳[1] 陈洪波[1] 马磊[1] ZHU Wenyong;CAI Wei;WANG Dongbao;YANG Wei;SUN Yi;HU Wenzhu;SONG Shaohui;LI Weidong;LIAO Guoyang;CHEN Hongbo;MA Lei(Institute of Medical Biology,Chinese Academy of Medical Sciences,Peking Union Medical College,Kunming 650118,China;Jiangsu Cheng Yu Mi Te Medical Technologies Co,Taizhou 225300,China)

机构地区：[1]中国医学科学院北京协和医学院医学生物学研究所,昆明650118 [2]江苏丞宇米特医疗科技有限公司,泰州225300

出　　处：《病毒学报》2020年第3期394-399,共6页Chinese Journal of Virology

基　　金：协和创新团队项目(项目号:2016‐I2M‐3‐026),题目:疫苗关键技术创新团队;云南省国际科技合作项目(项目号:2017IB008),题目:替代活病毒中和试验评价脊髓灰质炎疫苗免疫效果和监测人体免疫保护力的关键技术国际合作研究。

摘　　要：全球消灭脊髓灰质炎野病毒后,必须全面使用脊髓灰质炎灭活疫苗(Inactivated poliovirus vaccine,IPV)才能维持无脊灰状态,然而IPV成本较高,难以满足全球需要。皮内免疫途径能够降低Sabin株脊髓灰质炎灭活疫苗(Vero细胞)(Inactivated poliovirus vaccine derived from Sabin strains,sIPV)的抗原量,本研究将评估无针皮内免疫sIPV的安全性及免疫原性。本研究采用中国医学科学院医学生物学研究所生产的sIPV进行1/5(0.1 ml)剂量无针皮内免疫接种Wistar大鼠,并设计全剂量肌肉免疫对照组以及无针皮内免疫阴性对照组,按0月、1月、2月基础免疫程序,于免疫前及每剂免疫后第30 d采血,检测血清中和抗体水平,评价免疫原性,并通过观察大鼠的皮肤刺激反应及豚鼠的全身过敏反应,评价安全性。Wistar大鼠3剂免疫后,1/5剂量皮内免疫组与全剂量肌肉免疫组Ⅰ、Ⅱ、Ⅲ型抗体阳转率均达到100%,各型别中和抗体几何平均滴度(Geometric mean titer,GMT)均远高于1∶8保护水平。大白鼠接种疫苗后体重增加,皮肤刺激试验及全身过敏反应试验结果表明无针皮内免疫sIPV具有良好的安全性。本研究结果表明sIPV疫苗无针皮内注射免疫安全、有效,并可降低sIPV的抗原量,可为全球消灭脊髓灰质炎提供可负担得起的疫苗。After the global eradication of wild poliovirus,it is necessary to fully use the inactivated poliovirus vaccine(IPV)to maintain polio-free status. However,the cost of IPV is too high to meet the global needs.Intradermal immunization can reduce the antigen level of inactivated poliovirus vaccine derived from Sabin strains(sIPV). This study will evaluate the safety and immunogenicity of sIPV by intradermal immunization with a needle-free device. In this study,the full dose intramuscular sIPV vaccine prepared by our institute was used as the control. The experimental and negative control groups were designed which were 1/5(0.1 ml)dose MIT needle-free intradermal sIPV group and 1/5(0.1 ml)dose MIT needle-free intradermal saline group. The Wistar rats in various groups were immunized with intramuscular or intradermal injections at 0,1 and 2 months.The blood samples were collected before immunization and on days 30 after each immunization. The levels of neutralizing antibodies were tested for evaluating immunogenicity. The safety was evaluated by observation of the skin irritation reaction in rats and the allergic reaction in guinea pigs. After the three-dose schedule in Wistar rats,the seroconversion rates of type Ⅰ,Ⅱ and Ⅲ of 1/5-dose needle-free intradermal group and full dose intramuscular group were all up to 100%. The neutralizing antibody level of all three types were much higher than the protective titer 1∶8. The weight of rats increased after vaccination. The results of skin irritation test and systemic anaphylaxis test showed that sIPV with the intradermal immunization had good safety profile. The results of this study show that sIPV with intradermal immunization is safe and effective,which could reduce the amount of sIPV antigen. It could make the sIPV affordable for the global polio eradication.

关 键 词：Sabin株脊髓灰质炎灭活疫苗(sIPV) 皮内免疫 安全性 免疫原性 

分 类 号：R373.2[医药卫生—病原生物学] R511[医药卫生—基础医学]