IMMUNOGENICITY OF PERTUSSIS TOXOID

本合同的目的是测试免疫原性和有效性 一种新的百日咳疫苗（氢灭活百日咳毒素 过氧化物）由发育和分子生物学实验室开发 免疫（LIFE），校内研究计划，NICHD。 本研究将 分两部分完成。 第一项试验将使用 两种疫苗接种方案。 60名儿童将获得 在3、5和12个月大时接种疫苗。 其他六十人将收到它， 3、5和7个月大。 根据本部分的结果， 测试疫苗效力的临床试验将采用 三千个孩子。 这将是一项随机双盲试验， 接种NICHD百日咳疫苗的儿童 与白喉和破伤风疫苗结合。 另一半会收到 只有白喉和破伤风疫苗。 孩子们会被跟踪 直到他们长到24个月大，以确定百日咳率， 每个研究组的不良反应。 这将使 研究人员计算了这种疫苗的有效率。 在 此外，该研究将涉及实验室程序的测试， 定期从一个亚组抽取的血液样本的抗体水平， 参加这两个部分中任何一个的儿童样本。 这将 允许确定免疫状态。

The purpose of this contract is to test the immunogenicity and efficacy of a new pertussis vaccine (pertussis toxin inactivated with hydrogen peroxide) developed by the Laboratory of Developmental and Molecular Immunity (LDMI), Intramural Research Program, NICHD. This study will be accomplished in two parts. The first will test the immunogenicity using two regimens of vaccine administration. Sixty children will be given the vaccine at 3, 5, and 12 months of age. The other sixty will receive it as 3, 5, and 7 months of age. Based upon the results of this part, a clinical trial to test the efficacy of the vaccine will be initiated using 3,000 children. This will be a randomized double blind trial with half of the children receiving an inoculation of the NICHD pertussis vaccine combined with diphtheria and tetanus vaccine. The other half will receive only the diphtheria and tetanus vaccines. The children will be followed until they reach 24 months of age to determine the rate of pertussis and adverse reactions among each of the study groups. This will enable the investigators to calculate an efficacy rate for this vaccine. In addition, the study will involved laboratory procedures for testing antibody levels from blood samples taken at regular intervals from a sub- sample of children participating in either of the two parts. This will permit the determination of immune status.