CAP:Evaluation of a Dengue Vaccine in Adults with Preexisting Flavivirus Immunity

CAP：对已有黄病毒免疫力的成人进行登革热疫苗评估

• 批准号: 9566742
• 负责人: Stephen Whitehead
• 金额: $ 6.52万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 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/9566742
• 关键词: Acceleration; Admixture; Adolescent; Adult; Age; Agreement; Area; Attenuated; Attenuated Vaccines; Biological Assay; Child; Clinical; Clinical Research; Clinical Trials; Controlled Clinical Trials; Dengue; Dengue Vaccine; Dose; Double-Blind Method; Enrollment; Evaluation; Flavivirus; Funding; Genetic; Goals; Human; Immune response; Immunity; Individual; Infant; Medical Research; National Institute of Allergy and Infectious Disease; Phase; Placebo Control; Program Evaluation; Safety; Serological; Thailand; Vaccination; Vaccines; Viremia; Virus; Work; age group; base; cohort; experience; follow-up; immunogenicity; programs; vaccine candidate

A detailed statement of work was prepared to describe the activities to be carried out by the AFRIMS group in Bangkok, Thailand. An Interagency Agreement (A-AI-12-051-0000-0000) was executed between NIAID and the U.S. Army Medical Research and Materiel Command and will become effective on 09-01-2012. This agreement will govern the activities between LID and AFRIMS and was funded by NIAID Concept Acceleration Program (CAP), LID and Division of Clinical research. CAP funding will be used to support this clinical trial, including the required serological assays, viremia assays, and other clinical activities associated with the evaluation of the tetravalent dengue vaccine. The purpose of this project is to evaluate a live attenuated tetravalent DENV vaccine candidate with regard to safety, tolerability, genetic stability, and immunogenicity in humans, and to study the host's immune response to these viruses. Vaccination will occur in an age de-escalation manner, beginning with adults, followed by adolescents, older children, and finally younger children. Six months after primary vaccination, adult subjects will receive a second dose of tetravalent vaccine and will be followed for an additional 6 months. Two different vaccine admixtures, TV003 and TV005 will be studied in adults. Other age cohorts will only receive TV005. The study will enroll 294 subjects in a double-blind, placebo-controlled clinical trial. Progress to date: The adult cohort received dose 1 on Dec 6, 2014 and dose 2 on June 6, 2015. The adolescent cohort received 1 dose on Mar 14, 2015 The older child cohort received 1 dose on Aug 1, 2015 The younger child cohort received 1 dose on Nov 7, 2015 All subjects are in the follow-up phase of the study. The follow-up period was initially set for 3 years, but the US FDA has asked that we follow-up individuals for a period of 5 years (based on the Sanofi-Pasteur Dengvaxia experience)

准备了一份详细的工作说明，描述 AFRIMS 小组在泰国曼谷开展的活动。 NIAID 与美国陆军医学研究和物资司令部签署了一项机构间协议 (A-AI-12-051-0000-0000)，该协议将于 2012 年 9 月 1 日生效。该协议将管理 LID 和 AFRIMS 之间的活动，并由 NIAID 概念加速计划 (CAP)、LID 和临床研究部门资助。 CAP 资金将用于支持这项临床试验，包括所需的血清学检测、病毒血症检测以及与四价登革热疫苗评估相关的其他临床活动。 该项目的目的是评估四价 DENV 减毒活疫苗候选物的安全性、耐受性、遗传稳定性和免疫原性，并研究宿主对这些病毒的免疫反应。疫苗接种将以年龄递减的方式进行，从成人开始，然后是青少年、年龄较大的儿童，最后是年龄较小的儿童。初次接种疫苗六个月后，成年受试者将接受第二剂四价疫苗，并继续随访 6 个月。两种不同的疫苗混合物 TV003 和 TV005 将在成人中进行研究。其他年龄组将仅接收 TV005。该研究将招募 294 名受试者参加双盲、安慰剂对照临床试验。 迄今为止的进展： 成人队列于2014年12月6日接受第1剂，于2015年6月6日接受第2剂。 青少年队列于 2015 年 3 月 14 日接受了 1 剂疫苗 年龄较大的儿童队列于 2015 年 8 月 1 日接受了 1 剂疫苗 年龄较小的儿童队列于 2015 年 11 月 7 日接种了 1 剂疫苗 所有受试者均处于研究的后续阶段。 随访期最初设定为3年，但美国FDA要求我们对个体进行5年的随访（基于赛诺菲巴斯德Dengvaxia的经验）