Department of Virology II, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashi-Murayama, Tokyo 208-0011, Japan.
Department of Virology II, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashi-Murayama, Tokyo 208-0011, Japan.
Vaccine. 2020 Apr 9;38(17):3295-3299. doi: 10.1016/j.vaccine.2020.03.027. Epub 2020 Mar 17.
The efficacy of a Sabin-derived inactivated polio vaccine (sIPV) can be evaluated by measuring the immunogenicity and the contents of D-antigens, which induce the neutralizing antibodies. The immunogenic potency test in rats was done as a national assay in Japan. The two manufacturers of sIPV in Japan have performed both assays since development, and there is no clear discrepancy between the results obtained in the two assays. To further know the relationship between the two assays, we analyzed the effects of the heat treatment of sIPV on the D-antigenicity and the immunogenicity. We observed that the marginal D-antigen that remained after the thermal treatment was capable of inducing relatively high neutralizing antibodies in rats. This indicates that the measurement of the D-antigen contents as part of the quality control of sIPV is more sensitive and appropriate to detect denatured vaccines.
评估沙宾减毒脊髓灰质炎疫苗（sIPV）的效力可以通过测量诱导中和抗体的免疫原性和 D 抗原含量来实现。在大鼠中的免疫原性效力测试已在日本被用作国家标准检测。日本的 sIPV 两家制造商自开发以来一直进行这两项检测，并且这两项检测的结果没有明显差异。为了进一步了解这两项检测之间的关系，我们分析了 sIPV 的热处理对 D 抗原性和免疫原性的影响。我们观察到，热处理后残留的边缘 D 抗原能够在大鼠中诱导相对较高的中和抗体。这表明，作为 sIPV 质量控制的一部分，D 抗原含量的测量对于检测变性疫苗更敏感和合适。
