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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 登革热是一种病毒，每年造成1亿例登革热病例，并且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载体。艾德斯egeypti和艾德斯白化病，这些疾病是为人类传播的。 由于与这种疾病有关的全球疾病负担，有效疫苗的发展是必须的。 在全球范围内，登革热病毒每年引起大量疾病和残疾。迫切需要一种安全有效的疫苗。 当前研究的目的是确定人类志愿者的安全性和有效性，用于新的登革热病毒疫苗。 这项研究是一项在健康志愿者中的随机，安慰剂对照的双盲研究。 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（Johns Hopkins）的同事已经测试了同一疫苗的另一种疫苗，并发现在人类志愿者的II阶段试验中，它是安全且耐受性的。 （Durbin等人Am J TropMed。Hyg。，65（5），2001：405-413）。 这项研究是一项随机的，安慰剂对照的，双盲的研究，对健康的男性和非怀孕的女性志愿者18-50岁，没有先前的黄病毒病史。 入学资格将基于病史，身体检查，肝和肾脏测试的结果，凝结研究，HIV测试，乙型肝炎和C筛查，妊娠试验，筛查以前的黄病毒感染和血液学筛查。 履行纳入和排除标准的志愿者将被招募参加。 每个治疗组中的志愿者将被随机分配以接收疫苗或安慰剂。 疫苗与安慰剂比率分别为2.5：1。 在剂量日，在审查了知情同意书后，每个组将通过皮下注射到上臂接种疫苗或安慰剂。 GCRC的医生和护士将在疫苗后对参与者进行监测。 经过短暂的观察期，他们将获得日记卡和温度计，并提供有关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，每周7天每天24小时可向他们提供。 每个志愿者将在学习第2、4、6、8、10、12、14、21、28、42和180的研究时返回GCRC，以与研究医师和血液工作进行短暂拜访。 血液工作的目的是监测该病毒血症的病毒血症，免疫学指数的水平，并在每个志愿者中遵循肾脏，肝脏和血液学功能。 这些访问将在研究期间继续。