INTERNATIONAL COLLABORATIVE STUDY OF POLIO REAGENTS

脊髓灰质炎试剂的国际合作研究

• 批准号: 3804813
• 负责人: L A SAWYER
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3804813
• 关键词: animal tissue; antiserum; attenuated microorganism; drug quality /standard; enzyme linked immunosorbent assay; epitope mapping; genetic strain; immunological substance; neutralizing antibody; poliomyelitis vaccine; virulence; virus antigen

A standard reproducible method for determining the potency of inactivated poliovirus (IPV) vaccines in vitro would be an important advance toward the eradication of polio. Protection against polio is provided by neutralizing antibodies with "D" antigen specificity. We have developed an ELISA test in which polyclonal antibody (which is "D" specific) is used for detection. Using our reagents as the standard we examined sera from other collaborating laboratories for the ability to measure the potency of IPV vaccines. We were able to examine polyclonal sera prepared in four different species including: rabbits, cows, horses and goats. We were also able to compare two different vaccine preparations of IPV, one made from wild poliovirus strains and the other from Sabin strains. Furthermore, we were able to examine reagents prepared with either the wildtype or Sabin strains of poliovirus. We have completed our evaluation of the available polyclonal sera and are in the process of evaluating different monoclonal antibodies with the various polyclonal antibodies. We have found that reagents prepared against wildtype poliovirus strains work in the ELISA assay with Sabin derived IPV and vice versa. These findings suggest that the attenuated strains (Sabin) when prepared as an inactivated vaccine retain antigens in common with the inactivated wildtype strains. Whether equivalent amounts of D antigen units used to formulate trivalent IPV derived from wildtype strains is necessary for IPV derived from Sabin strains is not yet known. We plan to continue with this evaluation and to include in vivo studies of potency in parallel with the ELISA evaluation. In addition, the sera will be tested in our laboratory for neutralizing antibodies. The site-specificity of our monoclonal antibodies will be determined by one of our collaborators.

一个标准的可重复的方法来测定灭活的 体外脊髓灰质炎病毒（IPV）疫苗将是一个重要的进展， 根除小儿麻痹症。预防脊髓灰质炎的保护措施由 具有"D"抗原特异性的中和抗体。我们已经开发了一个 使用多克隆抗体（"D"特异性）的ELISA试验 用于检测。用我们的试剂作为标准品，我们检测了来自 其他合作实验室的能力，以衡量的效力， IPV疫苗。我们能够检测在四个不同的组织中制备的多克隆血清， 不同的物种，包括：兔子，牛，马和山羊。我们也 能够比较两种不同的IPV疫苗制剂，一种由 野生脊髓灰质炎病毒株和另一种来自Sabin株。而且我们 能够检测用野生型或Sabin制备的试剂 脊髓灰质炎病毒株。我们已经完成了对现有的 多克隆血清，并正在评估不同的单克隆抗体， 抗体与各种多克隆抗体。我们发现 针对野生型脊髓灰质炎病毒株制备的试剂可用于ELISA 用Sabin衍生的IPV进行测定，反之亦然。这些发现表明 制备灭活疫苗时，减毒株（Sabin） 保留与灭活野生型菌株相同的抗原。是否 用于配制三价IPV的等量D抗原单位 来源于野生型菌株是来源于Sabin的IPV所必需的 菌株尚不清楚。我们计划继续进行这项评估， 包括与ELISA评价平行的体内效价研究。 此外，血清将在我们的实验室进行中和试验 抗体的我们的单克隆抗体的位点特异性 由我们的一位合作者决定