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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 To evaluate the immunogenicity of domestic freeze-dried non-adjuvanted Vero cell rabies vaccine. Methods The past history of vaccination and history of canine rabies in rabies vaccination was unselected. The criteria of inclusion and exclusion criteria were established according to the criteria of research protocol. The patients were exposed to rabies by conventional 5-needle injection. Subjects were observed before the first needle inoculation, the first needle after vaccination 7,14,28,45 d, 6 months after the whole blood samples were collected to detect anti-rabies neutralizing antibodies. Results Subjects eligible for inclusion and exclusion criteria Ninety routine inoculated 5-needle lyophilized unadjuvanted Vero cell rabies vaccine. Rabies antibodies were all negative before vaccination. Rabies antibody positive rate was 12.22% at 7 days after inoculation and 100% at 14 days after inoculation of first needles. The first 45 days after inoculation and the second after 6 months The positive rate was 100%. The average geometric antibody titer (GMT) of anti-rabies virus combined antibody was only 0.27 IU / ml at 7 days after inoculation and the GMT of rabies antibody reached 2.52 IU / ml at 14 days after inoculation, which was 9.33 times higher than that at 7 days after inoculation . The GMT of Rabies antibody reached 4.43 and 7.08 IU / ml respectively at 28 and 45 days after inoculation, which were 1.76 and 2.81 times higher than that of the first day after vaccination. The GMT of rabies antibody still reached 8.41 IU / ml at 6 months after inoculation. Conclusion The domestic freeze-dried non-adjuvanted Vero cell rabies vaccine has good immunogenicity, and rabies vaccine animals can be re-exposed to rabies within 6 months.