CLINICAL TRIAL: PHASE I EVALUATION OF A LIVE ATTENUATED DEN4 VACCINE

临床试验：DEN4 减毒活疫苗的 I 期评估

• 批准号: 8166998
• 负责人: Beth Diane Kirkpatrick
• 金额: $ 49.21万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166998
• 关键词: Aedes; Age-Years; Asians; Attenuated; Baltimore; Blood; Cause of Death; Child; Clinical Trials; Coagulation Process; Computer Retrieval of Information on Scientific Projects Database; Country; Dengue; Dengue Virus; Development; Disease; Dose; Double-Blind Method; Effectiveness; Eligibility Determination; Enrollment; Evaluation; Exclusion Criteria; Female; Flavivirus Infections; Funding; Grant; Hematology; Hepatitis B; Hour; Human; Human Volunteers; Human immunodeficiency virus test; Immunologics; Informed Consent; Institution; Instruction; Kidney; Life; Liver; Maryland; Medical History; Monitor; Nurses; Participant; Phase; Phase II Clinical Trials; Physicians; Placebo Control; Placebos; Pregnancy Tests; Randomized; Recording of previous events; Recruitment Activity; Research; Research Personnel; Resources; Safety; Screening procedure; Source; Subcutaneous Injections; Testing; Thermometers; United States National Institutes of Health; Universities; Upper arm; Vaccines; Viremia; Virus; Visit; Work; base; burden of illness; diaries; disability; healthy volunteer; indexing; male; pregnant; response; vector mosquito; volunteer

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Dengue is a virus which is responsible for 100 million cases of dengue fever annually, and is one of the leading causes of death in children in several Asian countries. The virus has two principal mosquito vectors; Aedes ageypti and Aedes albopictus, which are responsible for transmitting disease to humans. Due to the global burden of illness associated with this disease, the development of an effective vaccine is imperative. On a global scale, the dengue virus causes a significant amount of illness and disability annually; a safe and effective vaccine is desperately needed. The aim of the current study is to determine the safety and effectiveness, in human volunteers, of a new lot of dengue virus vaccine. This study is a randomized, placebo-controlled, double-blind study in healthy volunteers. We will be conducting this study in conjunction with Johns Hopkins University in Baltimore, Maryland. Our colleagues at Johns Hopkins have already tested a different lot of this same vaccine and found it to be safe and well-tolerated in initial Phase II trials in human volunteers. (Durbin et al. Am J Trop Med. Hyg., 65(5),2001:405-413). This study is a randomized, placebo-controlled, double-blind study of healthy male and non-pregnant female volunteers 18-50 years of age with no history of a previous flavivirus infection. Eligibility for enrollment will be based on results of medical history, physical exam, liver and kidney testing, coagulation studies, HIV testing, hepatitis B and C screening, pregnancy testing, screening for previous flavivirus infection and hematology screening. Volunteers who fulfill inclusion and exclusion criteria will be recruited to participate. Volunteers in each treatment group will be randomly assigned to receive either the vaccine or placebo. The vaccine to placebo ratio will be 2.5:1 respectively. On dosing day, after review of the informed consent, each group will receive either vaccine or placebo via subcutaneous injection into their upper arm. The participants will be monitored after the vaccine by physicians and nurses at the GCRC. After a brief observation period they will be given diary cards and thermometers with instructions on how to use them. Volunteers will also receive contact information for the study doctor who will be available to them 24 hours a day 7 days a week for the duration of the study. Each volunteer will return to the GCRC on study days 2, 4, 6, 8, 10, 12, 14, 21, 28, 42 and 180 for a brief visit with the study physician and blood work. The purpose of the blood work is to monitor the level of viremia, immunologic indices in response to this viremia, and to follow kidney, liver and hematologic function in each volunteer. These visits will continue for the duration of the study.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 登革热是一种病毒，每年导致1亿例登革热病例，是几个亚洲国家儿童死亡的主要原因之一。该病毒有两个主要的蚊子媒介：阿吉伊蚊和白纹伊蚊，它们负责将疾病传播给人类。由于与这种疾病相关的全球疾病负担，开发有效的疫苗势在必行。在全球范围内，登革热病毒每年造成大量疾病和残疾；迫切需要一种安全有效的疫苗。 目前这项研究的目的是确定一批新的登革热病毒疫苗在人类志愿者中的安全性和有效性。这项研究是一项在健康志愿者中进行的随机、安慰剂对照、双盲研究。我们将与马里兰州巴尔的摩的约翰·霍普金斯大学一起进行这项研究。我们在约翰·霍普金斯大学的同事已经对这种疫苗进行了不同数量的测试，并在人类志愿者的初始第二阶段试验中发现它是安全的和耐受性良好的。(德宾等人)我是Jtrop Med。HYG，65(5)，2001：405-413)。 这项研究是一项随机、安慰剂对照、双盲研究，对象为18-50岁、无黄病毒感染病史的健康男性和未怀孕女性志愿者。登记的资格将基于病史、体检、肝和肾脏测试、凝血研究、艾滋病毒测试、乙肝和丙型肝炎筛查、怀孕测试、既往黄病毒感染筛查和血液学筛查的结果。符合纳入和排除标准的志愿者将被招募参与。每个治疗组的志愿者将被随机分配接受疫苗或安慰剂。疫苗与安慰剂的比例将分别为2.5：1。 在给药当天，在审查知情同意后，每组都将通过上臂皮下注射接种疫苗或安慰剂。疫苗接种后，GCRC的医生和护士将对参与者进行监测。在短暂的观察期后，他们将得到日记卡和温度计，以及如何使用它们的说明。志愿者还将收到研究医生的联系信息，在研究期间，研究医生将每周7天每天24小时为他们提供服务。每名义工将于研习第2、4、6、8、10、12、14、21、28、42及180天返回研习中心，与研习医生作一次简短的探访及血液化验。血液工作的目的是监测病毒血症的水平，以及针对这种病毒血症的免疫学指标，并观察每个志愿者的肾、肝和血液学功能。这些访问将在研究期间继续进行。