人用狂犬病纯化疫苗(Vero细胞)临床观察及免疫学效果研究

Immunogenicity and safety of purified Uero-cell rabies vaccine for human use

目的 研究人用狂犬病纯化疫苗的安全性和保护性。方法 采用狂犬病疫苗暴露后免疫程序接种受试人群 ,I期临床接种 2 0人 ,II、III期临床接种 30 4人 ,观察注射后反应 ,采用小鼠脑内中和试验法测定其中 6 2人中和抗体水平。结果 全部受试者有 13.2 7%出现轻度副反应 ,无中强度副反应 ,中和抗体阳转率为 10 0 % ,中和抗体GMT为 11.89IU/ml。

Aim To study the immunogenicity and safety of purified Vero cell rabies vaccine for human use.Methods All patients were treated by post exposure immune procedure.20 persons were evaluated in phage I clinical trial,while 304 persons were inoculated in phase II?III clinical trial.All reactions were noted down in detail,and among them 62 patients' antibody titers were determined using mouse neutralization test.Results Only 13.27% of all the subjects had low adverse reaction,no severe local and systemic reactions were reported in each stage of the study.The seropositive ratio is 100% and their GMT is 11.89IU/ml.Conclusion Purified Vero cell rabies vaccine is safe and effective.