IMMUNOGENICITY OF PERTUSSIS TOXOID

本合同的目的是测试疫苗的免疫原性和有效性 一种新的百日咳疫苗(百日咳毒素氢气灭活 过氧化氢)由发育和分子实验室开发 免疫(LDMI)，校内研究计划，NICHD。这项研究将是 分两部分完成。第一个将测试免疫原性，使用 两种疫苗接种方案。60名儿童将获得 在3、5和12个月龄时接种疫苗。其他60人将收到它作为 3个月、5个月和7个月大。根据本部分的结果， 将启动临床试验，以测试疫苗的有效性 3000个孩子。这将是一项随机双盲试验，有一半 接种NICHD百日咳疫苗的儿童 与白喉和破伤风疫苗相结合。另一半人将收到 只有白喉和破伤风疫苗。孩子们会被跟踪 直到它们长到24个月大，以确定百日咳的发病率和 各研究组的不良反应。这将使 调查人员需要计算这种疫苗的有效率。在……里面 此外，这项研究将涉及实验室测试程序 每隔一段时间从亚健康人群中采集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。这将是 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.