IMMUNOGENICITY OF PERTUSSIS TOXOID

百日咳类毒素的免疫原性

• 批准号: 2316471
• 负责人: JOHN TARANGER
• 金额: $ 100万
• 依托单位: GOTEBORG UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-09-30 至 1995-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2316471
• 关键词: IMMUNOGENICITY; PERTUSSIS; TOXOID

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.

本合同的目的是测试免疫原性和功效 一种新型百日咳疫苗（用氢气灭活百日咳毒素 过氧化物）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 分两部分完成。 第一个将使用测试免疫原性 两种疫苗接种方案。 六十名儿童将获得 3、5 和 12 个月龄时接种疫苗。 另外六十人将收到它 3、5、7个月大。 根据本部分的结果， 将启动测试疫苗功效的临床试验 3,000 名儿童。 这将是一项随机双盲试验，其中一半 接受 NICHD 百日咳疫苗接种的儿童 与白喉和破伤风疫苗联合使用。 另一半将收到 仅白喉和破伤风疫苗。 孩子们将被跟随 直到他们年满 24 个月时才能确定百日咳发病率和 每个研究组之间的不良反应。 这将使 研究人员计算该疫苗的有效率。 在 此外，该研究将涉及实验室测试程序 定期从亚组采集的血液样本中的抗体水平 参与两个部分中任何一个部分的儿童样本。 这将 允许确定免疫状态。