人用Vero细胞狂犬病疫苗暴露前免疫的安全性和免疫效果观察

Preexposure Studies on Purified Vero Cell Rabies Vaccine (PVRV): Serological and Clinical Responses in Human

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。

Objective In order to study serological and clinical responses in human of preexposure with purified Vero Cell rabies vaccine. Methods We carried out 65 subjects. When administered according to the recommended immunization schedule of WHO （0,7,28 day）, the booster injection at 1 year（365）. Immunogenicity was evaluated by titration of neutralizing antibodys with MNT. Results Local and systemic adverse reactions were not reported in all subjects. Only one antibody titers of= 0.5IU/mL prevaccination, none of the rest subjects had a detectable prevaccination antibody titer.On day 45, 365, and 385,seroconversion rates was 100.0% ,90.57% , and 100.0% respectively.On day 45, 365, and 385, geometric mean titers （GMT） was 12.82,1.57, and 40.49, respectively. Conclusion The vaccine is safe and effective before exposure.