国产无佐剂Vero细胞狂犬病疫苗接种后的不良反应及免疫持久性观察  

Adverse reactions and immune-persistence after immunization with domestic adjuvant-free rabies vaccine prepared with Vero cells

作　　者：钱晓华[1] 徐葛林[2] 吴志芳[1] 杨彦基[1] 徐巍[1] 戴梅英[3] 闫莉蓉[3] 曹芳[3] 牛亿军[3] 

机构地区：[1]上海市虹口区疾病预防控制中心,上海200082 [2]武汉生物制品研究所有限责任公司,湖北武汉430060 [3]上海市第一人民医院分院,上海200081

出　　处：《中国生物制品学杂志》2013年第10期1467-1471,共5页Chinese Journal of Biologicals

基　　金：上海市卫生局科研立项课题(2008205)

摘　　要：目的观察国产无佐剂Vero细胞狂犬病疫苗全程接种后的不良反应和免疫持久性,为完善再次暴露后疫苗的免疫程序提供依据。方法将医院犬伤门诊暴露后前来进行狂犬病疫苗接种者分为A、B两组:A组为Ⅱ级咬伤者,全程仅接种国产无佐剂Vero细胞狂犬病疫苗;B组为Ⅲ级咬伤者,接种国产无佐剂Vero细胞狂犬病疫苗加人狂犬病免疫球蛋白。电话调查并记录观察对象接种每剂无佐剂Vero细胞狂犬病疫苗及人狂犬病免疫球蛋白后7 d内的不良反应以及随访期间严重不良反应情况;接种前、接种后6周、6月、1年、2年、3年分别采集血清,采用快速荧光灶抑制试验(rapid fluorescent focus inhibition test,RFFIT)检测狂犬病病毒中和抗体,分析中和抗体≥0.5 IU/ml的有效保护水平以及抗体几何平均滴度(GMT)。结果疫苗接种后7 d内和随访期间未发生严重不良反应。疫苗接种后6周、6月、1年、2年、3年有效保护中和抗体(≥0.5 IU/ml)阳性率分别为97.5%、100%、73.9%、21.1%、20%;中和抗体GMT分别为4.584 6、2.226 9、1.146 6、0.506 3、0.408 5,中和抗体水平随着时间的延长呈显著下降趋势(P<0.01);加强免疫后中和抗体水平显著升高,并持续较长时间。结论国产无佐剂Vero细胞狂犬病疫苗的安全性和耐受性良好,接种后2年抗体水平降至与接种后3年相近的低水平,建议2年后再次暴露者全程接种5剂狂犬病疫苗。Objective To observe the adverse reaction and immune-persistence after complete immunization with domes- tic adjuvant-free rabies vaccine prepared with Vero cells, and provide a basis for improvement of immune schedule of the vaccine after further exposure. Methods The victims visiting clinics were divided into two groups. The victims of grade Ⅱ were served as group A, and received a complete immunization with domestic adjuvant-free rabies vaccine prepared with Vero cells, while those of gradeⅢ were served as group B and received a complete immunization with domestic ad- juvant-free rabies vaccine plus human rabies immnnoglobulin. The adverse reactions within 7 d after immunization with the vaccine or immunoglobulin, as well as the severe adverse reactions during the whole follow-up period, were investi- gated by telephone. Blood samples were collected before immunization and 6 weeks, 6 months, one year, 2 years and 3 years after immunization respectively, and determined for neutralizing antibody against rabies virus by RFFIT, based on which the positive rates of protective neutralizing antibody （not less than O. 5 IU/ml） and GMTs of antibody were ana- lyzed. Results No severe adverse reactions were reported during the whole follow-up period. The positive rates of protec- tive neutralizing antibody （not less than 0. 5 IU/ml） 6 weeks, 6 months, 1 year, 2 years and 3 years after immunization were 97.5%, 100%, 73. 9%, 21. 1% and 20%, while the GMTs of neutralizing antibodies were 4. 584 6, 2. 226 9, 1. 146 6, 0. 506 3 and 0. 408 5 IU/ml, respectively, indicating a significantly decreasing tendency of neutralizing anti-body level （P 〈 0. 01 ）. However, after booster immunization, the neutralizing antibody level increased significantly and last for a long time. Condution Domestic adjuvant-free rabies vaccine prepared with Vero cells was safe and well-tolerat- ed. However, the antibody level 2 years decreased to that 3 years after immunization. A complete immunization with rabies vaccine is recommende

关 键 词：狂犬病疫苗 VERO细胞 不良反应 中和抗体 持久性 

分 类 号：R373.9[医药卫生—病原生物学] R392-33[医药卫生—基础医学]