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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。
Objective To compare the antigenicity and immunogenicity of Sabin-IPV from three different manufacturers. Methods ELISA method was used to detect Sabin poliovirus D antigen content by serological and antigenic site-specific monoclonal antibody. The relative antigenicity of vaccine against D antigen and monoclonal antibody was analyzed to evaluate vaccine antigenicity. The immunogenicity of the Sabin poliovirus vaccine was analyzed using an in vivo efficacy test in rats to assess vaccine efficacy. Results Compared with Pu91, which is a c IPV standard in the UK, the Sabin poliovirus vaccine against three strains showed a relative D antigen content, of which C had the highest relative D antigen level. Serum type Ⅰ Sabin strain spinal cord There was no significant difference in antigenicity of the vaccine against the plague virus. In the serum type II, except Sabin poliovirus vaccine of producer B had a weaker antigenicity at antigenic site 1, Sabin strains of two manufacturers of A and C There was no significant difference in the antigenicity of the poliovirus vaccine; among the three serotypes, there was significant difference between the vaccine and antigenicity of the Sabin poliovirus vaccine in serotype III. Rat sera vaccinated with the Sabin poliovirus vaccine had good neutralizing potency against Sabin and Salk strains. Conclusion The antigenicity of the serotype Ⅰ and type Ⅱ Sabin poliovirus vaccine was the same as that of the vaccine except serum type Ⅲ. ELISA antigenicity detection method is expected to replace vaccine in vivo efficacy of animal tests.