国产冻干人用狂犬病疫苗(Vero细胞)的接种反应及其免疫原性  

Adverse Reaction and Immunogenicity of Domestic Freeze-dried Rabies Vaccine(Vero Cells)for Human Use

作　　者：王凌云[1] 孙美平[1] 张雪春[1] 徐若辉[2] 邹艳杰[3] 左永波 齐华[5] 

机构地区：[1]北京市疾病预防控制中心,北京100013 [2]北京市海淀区疾病预防控制中心,北京100037 [3]北京市东城区疾病预防控制中心,北京100009 [4]北京市海淀医院,北京100080 [5]北京市第六医院,北京100007

出　　处：《中国生物制品学杂志》2008年第12期1115-1117,共3页Chinese Journal of Biologicals

摘　　要：目的观察国产冻干人用狂犬病疫苗(Vero细胞)的接种反应及其免疫原性。方法观察组200例和对照组50例暴露后,按照0、3、7、14、28d免疫程序,分别接种国产、进口冻干人用狂犬病疫苗(Vero细胞)。观察组接种疫苗后,观察全身和局部反应情况。采用快速荧光灶抑制试验(RFFIT)检测观察组和对照组接种后的血清中和抗体水平。结果观察组疫苗接种后,局部红肿、硬结、疼痛、瘙痒发生率分别1.4%、0.8%、17.1%和2.4%;全身反应发热、皮疹、头痛、疲劳乏力和其他反应发生率分别为1.2%、0.4%、2.4%、4.2%和0.3%,且在第7天完全消失。观察组与对照组疫苗首剂接种后7d,抗体阳转率分别为40.3%和37.0%,14d分别为95.5%和97.7%,差异无统计学意义;且首剂接种后45d,抗体阳转率均为100%。观察组和对照组疫苗首剂接种后7、14、45d,血清中和抗体GMT差异无统计学意义,14、45d血清中和抗体GMT均大于0.5IU/ml。结论国产冻干人用狂犬病疫苗(Vero细胞)接种反应轻微,并具有良好的免疫原性。Objective To observe the adverse reaction and immunogenicity of domestic freeze-dried rabies vaccine （Vero cells）for human use. Methods A total of 200 victims were inoculated with domestic freeze-dried rabies vaceine（Vero cells）, according to a schedule of 0, 3, 7, 14 and 28 d, using 50 victims inoculated with imported freeze-dried rabies vaccine （Vero cells） as control. The local and systemic adverse reactions were observed, and the serum neutralizing antibody level after inoculation was determined by RFFIT. Results The incidences of local redness and swelling, scleroma, pain and itching after inoculation with domestic vaccine were 1.4%, 0.8%, 17.1% and 2.4%, and those of fever, rash, headache, fatigue and other reactions were 1.2%, 0. 4%, 2. 4%, 4. 2% and 0. 3%, respectively. All the reactions disappeared within 7 d after inoculation. The positive conversion rates of serum neutralizing antibody 7 d after inoculation with the 1st dose of domestic and imported vaccines were 40. 3% and 37. 0%, and those 14 d after inoculation were 95. 5% and 97. 7% respectively, which showed no significant difference. Both the antibody positive conversion rates 45 d after the 1st dose of domestic and imported vaccines were given were 100%. No significant differences were observed in the GMTs of serum neutralizing antibody 7, 14 and 45 d after inoculation with the 1st dose of domestic and imported vaccines, and all the GMTs 14 and 45 d after inoculation were more than 0. 5 IU/ml. Conclusion Domestic freeze-dried rabies vaccine （Vero cells） for human use induced mild adverse reactions and showed good immunogenicity.

关 键 词：冻干人用狂犬病疫苗 VERO细胞 接种反应 免疫原性 

分 类 号：R186[医药卫生—流行病学] R392-33[医药卫生—公共卫生与预防医学]