DEVELOPMENT OF TESTS FOR ACELLULAR PERTUSSIS VACCINES

由于与施用全细胞相关的副作用， 疫苗方面，开发改良百日咳疫苗是高度优先事项。 食品和药物管理局负责确保这些 疫苗既安全又有效。 因此，我们制定了 一系列试验来测试这些疫苗的安全性和效力。 这些 试验测试疫苗的纯度，无毒性， 回复到毒性形式和免疫原性。 特别是， 建立了无细胞百日咳疫苗的效价测定方法 其可用作再现性的可靠量度， 生产这些疫苗。 目前正在进行标准化ELISA 这项研究将测量小鼠对四种疫苗的免疫反应， 无细胞百日咳疫苗中发现的抗原。 这些抗原 丝状血凝素、百日咳类毒素、69 kDa蛋白和菌毛。 授权=Z01BA07020 百日咳实验室负责对以下物质进行常规控制检测： 百日咳疫苗效力和毒性。 的毒性和效力， 百日咳疫苗成分的许可疫苗进行测试之前， 产品可以释放。 百日咳实验室的控制测试用于确定 美国许可机构发放的百日咳疫苗成分 在整个有效期内具有足够和稳定的效力， 避免因毒性引起的不良反应 效价、稳定性和总保护单位的满意估计值 使用小鼠作为动物模型确定人免疫剂量。 在 此外，小鼠用于通过早期观察来确定疫苗毒性， 以及后期的体重变化。 除了对每种疫苗进行实验室检查外， 放行，控制测试包括审查制造商的方案， 令人满意的生产方法和控制测试进行的 制造商 在本报告所述期间， 提交放行的百日咳疫苗的效力和毒性， 知道了 在材料允许的情况下，百日咳实验室也进行控制 对国外生产商的疫苗进行检测，并作为参考 世界卫生组织的检测实验室。

Because of adverse effects associated with the administration of whole cell vaccine, development of improved pertussis vaccines is of high priority. The Food and Drug Administration is responsible for ensuring that these vaccines are both safe and effective. We have therefore developed a battery of assays to test the safety and potency of these vaccines. These assays test the vaccines for purity, lack of toxicity, lack of the ability to revert to a toxic form, and immunogenicity. In particular, efforts have been expended to develop a potency assay for acellular pertussis vaccine which can be used as a reliable measure of the reproducibility of manufacture of these vaccines. A standardized ELISA is currently being developed which will measure the immune response in mice to the four antigens found in acellular pertussis vaccines. These antigens are filamentous hemagglultinin, pertussis toxoid, 69 kDa protein, and fimbriae. GRANT=Z01BA07020 The Laboratory of Pertussis is responsible for routine control testing of pertussis vaccine potency and toxicity. The toxicity and potency of the pertussis vaccine component of licensed vaccines are tested before the product can be released. Control testing in the Laboratory of Pertussis is used to determine that the pertussis component of vaccine issued by U.S. licensed establishments have adequate and stable potency through the dating period and are free from untoward reactivity due to toxicity. Satisfactory estimates of potency, stability and protective units per total human immunizing dose are determined using mice as animal models. In addition, mice are used to determine vaccine toxicity by observing early and late weight changes. In addition to laboratory examination of each vaccine submitted for release, control testing involves reviewing the manufacturer's protocol for satisfactory production methods and control tests performed by the manufacturer. During the period described by this report, no significant changes in potency and toxicity of pertussis vaccines submitted for release were noted. When materials allow, the Laboratory of Pertussis also performs control testing on vaccines from foreign manufacturers and serves as a reference testing laboratory for the World Health Organization.