人用冻干无佐剂狂犬病疫苗的临床观察

目的观察人用冻干无佐剂狂犬病疫苗(武生欣宁)接种人体后的临床反应和免疫效果。方法40名健康者分别于0、3、7、14和28d接种疫苗,观察接种者副反应,并于接种后采血,用快速荧光灶抑制试验检测血清中和抗体水平。结果第1针和第2针接种后副反应率分别为2.5%和7.9%,后3针副反应率为0。免疫前抗体均为阴性,接种后第7天抗体阳转率为76%,第14天抗体水平GMT为9.42IU/ml,阳转率100%,第28天抗体水平GMT为9.83IU/ml,阳转率100%。结论人用冻干无佐剂狂犬病疫苗反应轻微,效果良好。

Clinical Trial of Adjuvant-free Freeze-dried Rabies Vaccine for Human Use

Objective To observe the safety and immune effect of adjuvant-free freeze-dried rabies vaccine for human use in volunteers.Methods Immunize 40 healthy volunteers with adjuvant-free freeze-dried rabies vaccine on days 0,3,7,14 and 28 respectively.Observe the adverse reaction and collect sera for determination of neutralizing antibody by RFFIT.Results The adverse reaction rates were 2.5% and 7.9% respectively after the 1st and 2nd doses,and were 0 after the 3rd,4th and 5th doses.All the antibodies of 40 volunteers were negative before immunization.However,the antibody positive conversion rates on days 7,14 and 28 were 76%,100% and 100% respectively.The GMTs of antibody on days 14 and 28 were 9.42 and 9.83 IU/ml respectively.Conclusion Adjuvant-free freeze-dried rabies vaccine for human use was safe and effective.