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目的为观察人用Vero细胞狂犬病疫苗暴露前免疫程序的安全性和效果。方法征集志愿者65人,暴露前接种3剂人用Vero细胞狂犬病疫苗,分别于第0d、7d、28d肌内注射。次年第1针免疫后的第365d加强1剂。用小鼠脑内中和试验测定其抗狂犬病病毒抗体。结果所有志愿者均未出现局部反应、全身反应和严重不良反应。65名志愿者在第1次接种前,除1名血清抗体为0.5IU/ml外,其余均未测出抗体。第45d、365d、385d的血清抗体阳转率分别为100.00%、90.57%、100.00%,几何平均滴度分别为12.82IU/ml、1.57IU/ml、40.49IU/ml。结论人用Vero细胞狂犬病疫苗在暴露前免疫程序安全且效果好。
The purpose is to observe the safety and efficacy of a pre-exposure immunization program for human Vero cell rabies vaccines. Methods Totally 65 volunteers were enrolled. Three rabbits vaccinated with Vero cells were administered before exposure and were injected intramuscularly on the 0d, 7d and 28d respectively. The first year after the first immunization after 365 days to strengthen one. Its anti-rabies virus antibody was tested in a mouse brain neutralization assay. Results All the volunteers did not appear local reaction, systemic reaction and serious adverse reaction. Before the first inoculation, 65 volunteers except for one serum antibody was 0.5 IU / ml, the other did not detect the antibody. The positive rates of seroconversion on the 45th day, 365th day and 385th day were 100.00%, 90.57% and 100.00% respectively. The geometric mean titers were 12.82 IU / ml, 1.57 IU / ml and 40.49 IU / ml, respectively. Conclusions Human Vero cell rabies vaccine is safe and effective before exposure.