无佐剂狂犬病疫苗的反应及免疫效果观察

目的观察无佐剂狂犬病疫苗的反应及免疫效果。方法以巴斯德PV2061为生产毒株,以143代以内的Ve-ro细胞为培养基质,采用生物反应罐灌流方式培养,连续收获病毒液,经浓缩、灭活、纯化,制成无佐剂Vero细胞狂犬病纯化疫苗。作为受试疫苗,按暴露后程序接种,无佐剂疫苗502人(A组),进口疫苗100人(对照组B组),观察反应和免疫效果。结果所有接种对象均未出现局部和全身强副反应。首剂免疫后14d,A组与B组抗体阳转率均达100%,中和抗体几何平均滴度为5.2IU/ml和5.6IU/ml。第45天A组抗体几何平均滴度上升到9.5IU/ml,B组9.8IU/ml。结论无佐剂狂犬病疫苗具有良好的安全性和免疫原性。

Safety and Immune Effect of Adjuvant-free Rabies Vaccine

Objective To observe the safety and immune effect of adjuvant-free rabies vaccine.Methods Inoculate Pasteur PV2061 strain of rabies virus into Vero cells less than 143 passages and incubate in bioreactor by perfused culture.Harvest the virus bulk continuously,then concentrate,inactivate and purify to prepare rabies vaccine.Immunize 502 victims(group A) with the vaccine by post-exposure schedule,using 100 victims(group B) immunized with the imported vaccine as control.Observe the adverse reactions and immune effects of the two groups.Results No severe local or systemic reactions were observed in the two groups.On day 14 after the first dose,both the antibody positive conversion rates of groups A and B reached 100%,and the GMTs of antibody were 5.2 and 5.6 IU/ml respectively.However,on day 45,the GMTs of groups A and B increased to 9.5 and 9.8 IU/ml respectively.Conclusion Adjuvant-free rabies vaccine showed good safety and immunogenicity.