Sabin-IPV抗原性及免疫原性分析

目的比较3个不同厂家的Sabin-IPV抗原性及免疫原性特点。方法采用ELISA方法,利用血清型和抗原位点特异性的单克隆抗体检测Sabin株脊髓灰质炎病毒疫苗D抗原含量,分析疫苗相对D抗原含量和单克隆抗体的相对反应性,评估疫苗抗原性;利用大鼠体内效力试验分析Sabin株脊髓灰质炎病毒疫苗的免疫原性,评估疫苗效力。结果与英国国家c IPV标准品Pu91相比,3个厂家的Sabin株脊髓灰质炎病毒疫苗相对D抗原含量存在差异,其中C厂家的相对D抗原含量最高;3个厂家的血清Ⅰ型Sabin株脊髓灰质炎病毒疫苗抗原性差异无统计学意义;血清Ⅱ型中,除B厂家的Sabin株脊髓灰质炎病毒疫苗的抗原位点1的抗原性较弱以外,A、C其2个厂家的Sabin株脊髓灰质炎病毒疫苗抗原性差异无统计学意义;血清Ⅲ型中,3个厂家的Sabin株脊髓灰质炎病毒疫苗与抗原性差异有统计学意义。接种Sabin株脊髓灰质炎病毒疫苗的大鼠血清对Sabin株及Salk株病毒具有良好中和效力。结论除血清Ⅲ型外,血清Ⅰ型和Ⅱ型Sabin株脊髓灰质炎病毒疫苗的抗原性与疫苗免疫原性一致。ELISA检测疫苗抗原性的方法有望替代疫苗动物体内效力评价试验。

Evaluation of antigenicity and immunogenicity of Sabin-IPV

Objective To compare antigenicity and immunogenicity of Sabin-IPV from different manufacturers. Metho- ds Relative D-Ag content and relative reactivity of Sabin-IPV were assessed when using a panel of monoclonal antibodies specific for serotypes and antigenic sites as detecting antibody in ELISA assay, Meanwhile, relative efficacy of Sabin-IPV was tested by the rat assay in vivo. Result Compared with Pu91, relative D-Ag content of obvious discrepancy between Sabin- IPV from three manufacturers was observed with highest relative D-Ag content from manufacturer C . Furthermore, there were striking differences in relative reactivity of serotype-Ⅲ Sabin-IPV with monoclonal antibodies, Sabin-IPV had good capacity to neutralize Sabin and Salk strains. Conclusion Compared with serotype-Ⅲ sIPV, there was better consistency between anti- genicity and immunogenicity specific for serotype Ⅰ and Ⅱ. In vivo rat assay for vaccine efficacy of serotype-Ⅰ and Ⅱ Sabin-IPV could be replaced with ELISA assay when using undermentioned monoclonal antibodies as detecting antibody.