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

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。

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

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 vaccine(Vero cells), accord- ing to a schedule of 0, 3, 7, 14 and 28 d, using 50 victims inoculated with imported freeze-dried rabies vaccine (Vero cells)as con- trol. The local and systemic adverse reactions were observed, and the serum neutralizing antibody level after inoculation was deter- mined 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.