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声明，以描述泰国曼谷的Afrims Group将要进行的活动。 NIAID与美国陆军医学研究和物料司令部之间执行了一项机构间协议（A-AI-12-051-0000-0000），并将在2012年9月1日生效。该协议将管辖盖子和Afrims之间的活动，并由NIAID概念加速度计划（CAP），临床研究的盖子和分工提供资金。 CAP资金将用于支持这项临床试验，包括与四龙龙鸡疫苗评估相关的所需血清学分析，病毒血症测定和其他临床活动。 该项目的目的是评估人类的安全性，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。疫苗接种将以年龄降低的方式发生，从成年人开始，然后是青少年，大儿童和最终年幼的孩子。初次疫苗接种后六个月，成年受试者将接受第二剂四剂量疫苗，并将再接受6个月的次数。成人将研究两种不同的疫苗混合物，TV003和TV005。其他年龄段只能接收TV005。该研究将在一项双盲，安慰剂对照的临床试验中招募294名受试者。 进度日期： 成人队列于2014年12月6日接受剂量1，并于2015年6月6日接受剂量2。 青少年队列于2015年3月14日接受1剂 年龄较大的儿童队列于2015年8月1日接受1剂 年轻的孩子队列于2015年11月7日接受1剂 所有受试者都处于研究的后续阶段。 后续期最初设定了3年，但美国FDA要求我们跟进个人5年（基于Sanofi-Pasteur Dengvaxia经验）