国产冻干无佐剂Vero细胞狂犬病疫苗接种效果观察  

Observation of the effects of inoculation with a domestic lyophilized non-adjuvanted rabies vaccine derived from Vero cells

作　　者：梁玉民[1] 

机构地区：[1]济宁市疾病预防控制中心,山东济宁272000

出　　处：《中国病原生物学杂志》2010年第6期421-423,429,共4页Journal of Pathogen Biology

基　　金：山东省济宁市科技攻关项目(No.2005GGB14666)

摘　　要：目的观察狂犬病暴露前人群应用国产冻干无佐剂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。方法选择犬密切接触人群,按照知情自愿的原则,对244名Ⅰ级狂犬病暴露者接种国产纯化冻干无佐剂Vero细胞狂犬病疫苗(PVRV),按照随机、单盲的原则分成两组,A组122人,分别于第0、7、28 d皮内注射,每个部位0.1 ml;B组122人,分别于第0、7、28 d全量(0.5 ml)PVRV三角肌注射。观察受种者疫苗注射部位皮内及肌肉局部和全身反应,采用间接ELISA法检测血清抗体。结果皮内注射组局部红肿、硬结、疼痛、瘙痒,发生率分别为1.09%、0.27%、0.27%和10.66%,肌肉注射组分别为0.82%、0.27%、1.64%和0.82%。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0.27%、0.27%、0.55%和0.82%,肌肉注射组分别为0.55%、0.27%、0.55%和0.82%。不良反应常发生在第1、第2次注射之后。皮内注射(ID)组、肌肉注射(I M)组接种狂犬病疫苗后42 d抗体阳转率分别是94.21%和95.08%,差异无统计学意义(P>0.05)。结论国产冻干Vero细胞狂犬病疫苗免疫原性良好,皮内、肌肉注射不良反应轻微。对暴露前人群小剂量皮内注射国产冻干无佐剂Vero细胞狂犬病疫苗是可行的。Objective To observe the immunogenicity of and reaction to a low-dose intradermal injection of a lyophilized rabies vaccine derived from Vero cells without adjuvant for a pre-exposure group.Methods In accordance with informed consent,a population in close contact with dogs was selected and 244 individuals with class I exposure to rabies received pre-exposure immunization.In a randomized,single-blind manner,subjects were divided into two groups： group A,an intradermal injection（ID） group of 122 individuals receiving an intradermal injection of 0.1ml vaccine at each site on D 0,7,and 28,and group B,an intramuscular injection（IM） group of 122 individuals receiving a full-volume（0.5 ml） PVRV injection in the deltoid on D 0,7,and 28.Local and systemic responses to the vaccine were observed with the different routes of injection.An indirect sandwich ELISA assay was used to analyze antibody levels.Results For the ID group,the incidence rates for local redness and swelling,induration,pain,and itching were 1.09%,0.27%,0.27%,and 10.66%,respectively.For the IM group,the incidence rates were 0.82%,0.27%,1.64%,and 0.82%,respectively.For the ID group,the incidence rates for systemic reactions in the form of fever,rash,headaches,and fatigue and weakness were 0.27%,0.27%,0.55%,and 0.82%,respectively,while similar incidence rates for the IM group were 0.55%,0.27%,0.55%,and 0.82%,respectively.Adverse effects often occurred following the 1st and 2nd injection.The respective seroconversion rates for the ID injection group and IM group were 94.21% and 95.08% after D 42 of immunization,and the difference in seroconversion rates was not statistically significant（P0.05）.Conclusion The domestic lyophilized rabies vaccine derived from Vero cells resulted in mild adverse reactions and had good immunogenicity.A domestic lyophilized rabies vaccine derived from Vero cells can,when given in low-dose intradermal injections without adjuvant,be used to vaccinate a pre-exposure group.

关 键 词：狂犬病 冻干Vero细胞狂犬病疫苗 皮内注射 肌肉注射 局部反应 全身反应 免疫原性 

分 类 号：R512.99[医药卫生—内科学]