INTERNATIONAL COLLABORATIVE STUDY OF POLIO REAGENTS

脊髓灰质炎灭活疫苗效力测定标准方法 将是根除小儿麻痹症的一个重要进展。脊髓灰质炎 疫苗效力难以在体外测量，因为“D”抗原 负责引发保护性中和抗体的细胞不能被 当使用多克隆血清用于检测时， 侦测针对D表位的单克隆抗体已经被发现。 但它们尚未在国际上分发使用， 标准化的方式。此外，尚不清楚疫苗的滴度如何 在ELISA中测量的效力与体外中和滴度比较 或在体内。更重要的是认识到，尽管 目前获得许可的产品是用野生型脊髓灰质炎病毒株制成的 未来的疫苗可以使用Sabin菌株来制造。野生型和 Sabin菌株在体外试验中反应不同，并引起不同的 中和抗体滴度。类型1、2和3的比例可以 对于新产品来说并不相同。此外，未来的脊髓灰质炎疫苗可能 与其他儿童疫苗一起生产， 必须了解其他的各种成分的影响 关于脊灰炎疫苗效力和测试脊灰炎疫苗的能力 力量因此，必须在国际上制定一项 公认的标准测定，可以考虑这些重要的 因素我们已经开始从参与者那里收集试剂 实验室，并将开始测试这些，以确定哪些是重要的 加入国际测试

A standard method for determining potency of inactivated polio vaccines would be an important advance toward the eradication of polio. Polio vaccine potency is difficult to measure in vitro because the "D' antigen responsible for eliciting protective neutralizing antibodies cannot be readily distinguished from the 'C' antigen when polyclonal sera is used for detection. Monoclonal antibodies directed toward the D epitope(s) have been made, but they have not been distributed for use internationally in a standardized way. Furthermore, it is not known how a titer of vaccine potency as measured in an ELISA compares with neutralizing titers in vitro or in vivo. Of additional importance is the recognition that although currently licensed products are made using wild-type strains of polio virus future vaccines may be manufactured using Sabin strains. The wild-type and Sabin strains react differently in in vitro tests and elicit different titers of neutralizing antibody. The proportion of types 1, 2, and 3, may not be the same for the newer products. Also, future polio vaccines may be manufactured in combination with other childhood vaccines, and it will be necessary to understand the effect of the various components of the other vaccines on polio vaccine potency and on the ability to test polio vaccine potency. Therefore, it is essential to develop an internationally recognized standard assay(s) which can take into account these important factors. We have begun to collect reagents from the participating laboratories and will begin to test these to determine which are important to include in an international test.