DEVELOPMENT OF TESTS FOR ACELLULAR PERTUSSIS VACCINES

由于与整个给药相关的不良反应， 细胞疫苗，开发改进的百日咳疫苗具有很高的 要务食品和药物管理局负责确保 这些疫苗既安全又有效我们因此 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。 这些试验测试疫苗的纯度，无毒性， 缺乏回复为毒性形式的能力和免疫原性。这些 已经对四批无细胞百日咳疫苗进行了试验， 在瑞典和意大利的大规模疗效试验中进行了评估， 其他疫苗目前处于IND和PLA状态。 正在努力开发和标准化效力和毒性测试 其可用作再现性的可靠量度， 这些疫苗的生产商。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 菌毛用于检测的适当对照试剂的制备如下： 正在进行中确定最佳免疫接种时间表的试点研究， 小鼠超免疫参考血清的制备已完成， 小鼠的免疫接种正在进行中。

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. These tests have been applied to four lots of acellular pertussis vaccines being evaluated in large scall efficacy trials in Sweden and Italy, as well as other vaccines currently under IND and PLA status. Efforts are underway to develop and standardize potency and toxicity tests which can be used as reliable measures of the reproducibility of manufacturers 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. The preparation of suitable control reagents for the tests are underway. A pilot study to define optimal immunization schedules in order to prepare mouse hyperimmune reference serum is complete and the immunization of mice is in progress.