目的 观察国产冻干无佐剂Vero细胞狂犬病疫苗小剂量皮内注射的接种反应及其免疫原性.方法 对256名Ⅱ级狂犬病暴露受试者进行暴露后免疫,按照随机、单盲的原则分成皮内注射组:皮内注射法组128人,按照0,3,7,28,90d作2点、2点、2点、1点、1点皮内注射,每个部位0.1ml;肌肉注射组:肌肉注射法组128人,按照0,3,7,14和28d接受全量(0.5ml)三角肌注射.使用国产冻干无佐剂Vero细胞狂犬病疫苗(PVRV).观察皮内及肌肉注射疫苗后的局部和全身反应情况.采用夹心间接ELISA法检测抗体水平.结果 暴露后皮内注射组局部红肿、硬结、疼痛、瘙痒,发生率分别为1.27%、0.29%、0.49%、11.43%,肌肉注射组分别为1.09%、0.16%、2.81%、1.41%.暴露后皮内注射组发热、皮疹、头痛、疲劳乏力等全身反应,发生率分别为0.31%、0.16%、0.31%、1.09%,肌肉注射组分别为0.31%、0.31%、0.63%、1.09%.所有副反应常发生在第1、第2次注射之后.暴露后免疫皮内注射、肌肉注射狂犬病疫苗后14d抗体阳转率分别是94.53%、95.31%,免疫后42d抗体阳转率分别是96.83%、97.64%.暴露后皮内、肌肉注射法,狂犬病疫苗抗体阳转率差异无统计学意义.结论 国产冻干Vero细胞狂犬病疫苗,接种反应轻微,免疫原性良好.%Objective To observe the vaccination reactions and immunogenicity of the application of lyophilized Vero cell rabies vaccine without adjuvant in a way of low-dose intradermal injection for post-exposure group. Methods Conducting post-exposure immunization for 256 persons with the class Ⅱ level exposure to rabies. Based on a randomized, single-blind principle, all subjects were divided into intradermal injection (ID) group (n= 128),injected 0.1 ml for each site in accordance with 0,3,7,28,90 d,2 sites,2 sites,2sites,1 site,1 site respectively, and intramuscular injection(IM) group(n= 128) in accordance with 0,3,7,14,28 d in full-volume (0.5ml) PVRV Deltoid injection. The local and systemic vaccination reactions were observed for the different injection ways. The indirect sandwich ELISA assay was used to analyze the antibody levels. Results For the intradermal injection group, the incidence rates for local redness and swelling, induration, pain, itch were 1.27%, 0.29% ,0.49% ,11.43% respectively,for the intramuscular group, the incidence rates were 1.09% ,0. 16% ,2. 81% ,1.41% respectively. From the point of systemic reactions,the incidence rates of fever,rash,headache,fatigue and weakness were 0.31 % ,0. 16% ,0. 31 % , 1.09% respectively in the intradermal injection group,and the rates were 0.31% ,0.31% ,0.63% , 1.09% respectively in intramuscular group. All the adverse effects often occurred following the 1st,2nd injection. The seroconversion rates for intradermal injection and intramuscular were 94.53% ,95.31% following 14 d immunization respectively,the rates were 96. 83% ,97.64% following 42 d immunization respectively. For the post-exposure group,no statistical difference in significance was found between the two seroconversion rates. Conclusion For the application of domestic lyophilized Vero cell rabies vaccine,its adverse reactions are mild,and immunogenicity is good.
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