冻干无佐剂Vero细胞狂犬病疫苗免疫应答动态观察  

A dynamic observation on the immune response to the freeze-dried without adjuvant Vero cell rabies vaccine

作　　者：杨书宏[1] 陈胤忠[2] 陈万庚 姜仁杰[2] 沈进进[2] 吴巨飞[2] 何飞[1] 王立成 

机构地区：[1]江苏省盐城市盐都区疾病预防控制中心,江苏盐城224001 [2]盐城市疾病预防控制中心 [3]长春长生生物科技有限公司

出　　处：《疾病监测》2009年第6期409-411,共3页Disease Surveillance

摘　　要：目的评价国产冻干无佐剂Vero细胞狂犬病疫苗的免疫原性。方法选择既往无明确狂犬病疫苗接种史和犬伤史、符合研究方案制定的入选标准和排除标准为研究对象,对暴露于狂犬病的患者采用常规5针注射。观察对象于首针接种前、首针接种后7、14、28、45d,全程后6个月采集血样检测抗狂犬病中和抗体。结果符合入选标准和排除标准的观察对象90名常规接种5针冻干无佐剂Vero细胞狂犬病疫苗。观察对象接种前狂犬病抗体均为阴性,接种首针后7d狂犬病抗体阳转率为12.22%,接种首针后14d阳转率达到100%,接种首针后28、45d和全程后6个月的阳性率均为100%。接种首针后7d抗狂犬病病毒综合抗体的几何抗体平均滴度(GMT)仅为0.27IU/ml,接种首针后14d狂犬病抗体的GMT达到2.52IU/ml,较首针接种后7d增长9.33倍。接种首针后28、45d狂犬病抗体的GMT分别达到4.43、7.08IU/ml,较首针后14d分别增长1.76倍、2.81倍。全程接种后6个月狂犬病抗体的GMT仍达到8.41IU/ml。结论国产冻干无佐剂Vero细胞狂犬病疫苗具有良好的免疫原性,6个月内再被暴露于狂犬病动物者可以不需要接种狂犬病疫苗。Objective The purpose of the present study was to evaluate the immunogenicity of the freeze-dried without adjuvant Vero cell rabies vaccine made in China. Methods A conventional vaccination procedure that included 5 injections of vaccine was applied to 90 patients who had exposed to rabies and were without history of rabies vaccination and dog bite injury, selected according to the requirements for recruitment and exclusion in the project. Blood samples were acquired before the first vaccination, 7, 14, 28 and 45 days after the first vaccination and 180 days after the whole procedure of vaceinatiun, respectively, for determination of anti-rabies neutralizing antibody. Results No anti-rabies neutralizing antibody was detected before the first vaccination in the subjects studied. The positive rate of anti-rabies neutralizing antibody was 12. 22% 7 days after the first vaccination, and reached to 100% 14 days after the first vaccination which remained until 180 days after the whole procedure of the vaccination. Antibody geometric mean concentration （GMT） of anti-rabies neutralizing antibody was found to be 0. 27 IU/ml 7 days after the first vaccination and raised to 2. 52 IU/ml 14 days after the first vaccination, increasing by 9.33 folds compared to that found 7 days after the first vaccination, and to 4. 43 and 7.08 IU/nll, respectively, 28 and 45 days after the first vaccination, increasing by 1.76 and 2.81 folds, respectively, compared to that detected 14 days after the fast vaccination. GMT of anti-rabies neutralizing antibody maintained at a high level （8.41 IU/ml） even 180 days after completion of the whole procedure of vaccination. Conclusion The freeze-dried without adjuvant Vero cell rabies vaccine made in China exhibited good immunogenicity. The people who have received vaccination within 6 months need not to be inoculated aeain when exoosed to animals with rabies.

关 键 词：冻干无佐剂狂犬病疫苗 VERO细胞 免疫原性 

分 类 号：R392[医药卫生—免疫学]