人用狂犬病无佐剂纯化疫苗的安全性与免疫原性的初步观察

目的评价国产人用狂犬病无佐剂纯化疫苗(Vero细胞微载体)的安全性和免疫原性。方法对502人(A组)接种人用狂犬病无佐剂纯化疫苗(Vero细胞微载体)另100人(B组)作为对照接种巴斯德公司生产的狂犬病纯化疫苗。采用0、3、7、14和28天程序,观察每针次接种后72小时内局部和全身反应及14天、45天的免疫应答水平。结果所有接种对象均未出现严重局部和全身副反应。首剂免疫14天,A、B组抗体阳性率均达到100%,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至9.5IU/mll,与B组相似(9.8IU/ml)。结论人用狂犬病无佐剂纯化疫苗(Vero细胞微载体)具有良好安全性和免疫原性。

Safety and immunogenicity of a new inactivated rabies vaccine (Vero Cell) in healthy adults

Objective To assess the safety and immunogenicity of a new inactivated rabies vaccine(Vero cell)in healthy adults.Methods502healthy individuals(group A)were received of home_made rabies vaccine(Vero cell)by Chengda Biotech.Co.Ltd,100(group B)were given the matched control rabies vaccine produced by Aventis Pasteur Co.Ltd.The immunity procedure was0,3,7,14and28days.The local and systemic side effects were recorded the first72hours after each vaccination.Seroconversion rate and geometric mean titer(GMT)of antibody to the virus of rabies were tested at days14and45after first dose of vaccination.Results Local and systemic serious reactions were not observed in all participants.14days after first dose of vaccination,the seroconversion rates of antibody IgG were100%in two groups,the titers of antibody were5.2IU/ml and5.6IU/ml in group A and B,respectively.45days after first dose of vaccination,GMTs went up9.5IU/ml and9.8IU/ml in group A and B,respectively.Conclusion The home_made inactivated rabies vaccine(Vero cell)was safe and highly immunogenic.