University of Washington Vaccine and Treatment Evaluation Unit

华盛顿大学疫苗和治疗评估单位

• 批准号: 10462171
• 负责人: Raymond Scott McClelland
• 金额: $ 42.76万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-20 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10462171
• 关键词: Address; Adult; Adverse event; Africa South of the Sahara; Area; Biological Assay; Cellular Immunology; Child; Childhood; Clinic; Clinical Investigator; Clinical Practice Guideline; Clinical Protocols; Clinical Research; Clinical Trials; Committee Members; Communicable Diseases; Conduct Clinical Trials; Contracts; Country; Cytomegalovirus; Data Analyses; Emerging Communicable Diseases; Enrollment; Ensure; Evaluation; Fred Hutchinson Cancer Research Center; Funding; Geography; Good Clinical Practice; HIV Vaccine Trials Network; Hepatitis; Human; Individual; Industry; Influenza; Influenza A Virus, H1N1 Subtype; Influenza A virus; Infrastructure; Institution; International; Kenya; Knowledge; Laboratories; Laboratory Research; Lead; Leadership; Location; Malaria; Medical Research; Medical center; Medicine; Mentorship; Mission; Molecular Virology; Monitor; National Institute of Allergy and Infectious Disease; Participant; Peripheral Blood Mononuclear Cell; Persons; Peru; Pharmaceutical Preparations; Phase; Policies; Population; Pregnant Women; Principal Investigator; Reporting; Research; Research Institute; Research Personnel; Resources; Respiratory Tract Infections; Ribosomal RNA; Risk; Running; Safety; Sexually Transmitted Diseases; Simplexvirus; Site; South Africa; Target Populations; Testing; Therapeutic; United States National Institutes of Health; Universities; Vaccine Clinical Trial; Vaccines; Washington; Women' s Health; Work; ZIKA; clinical development; clinical research site; cost; design; enteric infection; experience; global health; healthy volunteer; industry partner; malaria infection; medical schools; neglected tropical diseases; novel; novel strategies; novel therapeutics; novel vaccines; pandemic disease; participant safety; programs; recruit; skills; training opportunity; vaccine development; vaccine trial

The proposed University of Washington (UW) Vaccine and Treatment Evaluation Unit (VTEU) will be led by highly experienced investigators in domestic and international clinical trials, and supported by a Steering Committee that includes leading experts in the areas of focus of this application, including respiratory infections, sexually transmitted infections, malaria challenge studies, enteric infections and other neglected tropical diseases. The co-Principal Investigators have conducted >30 clinical trials, most under IND; these include trials sponsored by NIAID, including VTEU contracts, HPTN and STI CTG, industry sponsors, and investigator-held IND. The proposed VTEU Research Clinic at Harborview Medical Center has been conducting clinical trials for several decades, and the recruitment, enrollment, and retention practices and policies have been well established. Our strong record in obtaining research funding has resulted in the UW School of Medicine providing ample space that has been specifically designed to accommodate clinical trials conducted in the area of Infectious Diseases. The UW VTEU will leverage the extraordinary breadth and depth of expertise, facilities, resources, populations, and geographic reach of the UW and our collaborating institutions. Locally, these include Seattle Children’s and the Fred Hutchinson Cancer Research Center, in addition to several campus locations for UW Medicine. Internationally, the investigators included in the UW VTEU also lead well-established and experienced research sites with outstanding infrastructure in Kenya (UW- Kenya and the Kenya Medical Research Institute), South Africa (University of Witwatersrand), and Peru (Asociación Civil Selva Amazónica). Both domestic and international investigators have vast experience in the conduct of clinical trials of vaccines and other therapeutics under IND, with many sponsored by NIAID. This consortium has demonstrated capacity to recruit and retain the populations targeted by the VTEUs, including healthy volunteers, pregnant women, children, persons with or at risk for sexually transmitted infections, and participants in human challenge studies. The Specific Aims of the UW VTEU are: 1. Recruit a wide range of participants in clinical trials approved by the Leadership Group; 2. Implement clinical trials in compliance with Good Clinical Practice Guidelines and other regulatory guidance; 3. Ensure participant safety and monitor trials for adverse events; 4. Support the Leadership Group in the development of clinical protocols, providing unique clinical and research laboratory capabilities, performing data analysis, and reporting the results of clinical trials; 5. Provide outstanding training opportunities and mentorship to early stage investigators who desire to gain experience in conducting clinical trials.

拟议的华盛顿大学（UW）疫苗和治疗评估部（VTEU）将由 在国内和国际临床试验中经验丰富的研究人员，并得到转向的支持 委员会包括该申请重点领域的主要专家，包括呼吸系统 感染，性传播感染，疟疾挑战研究，肠感染和其他被忽视的 热带疾病。共同主要研究人员在IND下进行了30次临床试验。这些 包括NIAID赞助的试验，包括VTEU合同，HPTN和STI CTG，行业赞助商以及 研究人员控制的印第安纳州。 Harbourview Medical Center拟议的VTEU研究诊所已经 进行临床试验数十年，以及招募，入学率和保留惯例 政策已经建立得很好。我们在获得研究资金方面的良好记录导致了UW 医学院提供的空间是专门设计的，可容纳临床试验 在传染病领域进行。 UW VTEU将利用非凡的宽度和深度 UW的专业知识，设施，资源，人群和地理范围以及我们的合作 机构。在当地，其中包括西雅图儿童和弗雷德·哈钦森癌症研究中心 除了多个校园医学校园外。在国际上，调查人员包括西澳大学 VTEU还领导肯尼亚拥有出色基础设施的良好和经验丰富的研究地点（UW- 肯尼亚和肯尼亚医学研究所），南非（威特沃特斯兰大学）和秘鲁 （Asociación民用SelvaAmazónica）。国内和国际调查人员在 在IND下进行疫苗和其他治疗剂的临床试验，其中许多由NIAID赞助。这 财团已证明有能力招募和保留VTEUS目标的人口，包括 健康的志愿者，孕妇，儿童，有性传播感染风险或有风险的人 人类挑战研究的参与者。 UW VTEU的具体目的是：1。招募广泛的范围 由领导小组批准的临床试验的参与者； 2。符合临床试验 良好的临床实践指南和其他监管指南； 3.确保参加安全和监控试验 用于广告活动； 4。支持领导力小组制定临床方案，提供独特 临床和研究实验室功能，进行数据分析以及报告临床试验结果； 5。为希望获得的早期调查员提供出色的培训机会和心态 进行临床试验的经验。