DEVELOPMENT OF TESTS FOR ACELLULAR PERTUSSIS VACCINES

无细胞百日咳疫苗检测方法的开发

• 批准号: 3811018
• 负责人: D L BURNS
• 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/3811018
• 关键词: bacterial proteins; diagnosis design /evaluation; enzyme linked immunosorbent assay; immunological substance; immunotoxicity; laboratory mouse; microorganism hemagglutinin; pertussis toxin; pertussis vaccine; pilus

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.

由于与整个给药相关的不良反应 细胞疫苗、改良百日咳疫苗的开发具有较高的价值 优先事项。 食品药品监管总局负责确保 这些疫苗既安全又有效。 因此我们有 开发了一系列检测方法来测试这些药物的安全性和效力 疫苗。 这些检测可测试疫苗的纯度、无毒性、 缺乏恢复为毒性形式的能力和免疫原性。 在 特别是，我们已努力开发一种效力测定方法，用于 无细胞百日咳疫苗可作为可靠的措施 这些疫苗生产的可重复性。 一个标准化的 目前正在开发 ELISA，它将测量免疫 小鼠对无细胞百日咳中发现的四种抗原的反应 疫苗。 这些抗原是丝状血凝素、百日咳 类毒素、69 kDa 蛋白质和菌毛。