University of Washington Vaccine and Treatment Evaluation Unit

拟议中的华盛顿大学（UW）疫苗和治疗评估单位（VTEU）将由以下人员领导： 在国内和国际临床试验中经验丰富的研究者，并得到指导 该委员会包括本申请重点领域的领先专家，包括呼吸系统 感染、性传播感染、疟疾挑战研究、肠道感染和其他被忽视的 热带疾病。共同主要研究者已经进行了超过30项临床试验，大多数在IND下;这些 包括由NIAID赞助的试验，包括VTEU合同、HPTN和STI CTG、行业赞助商，以及 拟议中的VTEU研究诊所在Harborview医疗中心已被 开展临床试验几十年，招募、入组和保留实践， 政策已经确立。我们在获得研究资金方面的良好记录导致了UW 医学院提供充足的空间，专门设计用于容纳临床试验 在传染病领域进行。UW VTEU将利用其非凡的广度和深度， 专业知识，设施，资源，人口和地理范围的华盛顿大学和我们的合作 机构职能体系在当地，这些包括西雅图儿童和弗雷德哈钦森癌症研究中心，在 除了几个校园地点为华盛顿大学医学。在国际上，包括华盛顿大学在内的研究人员 VTEU还在肯尼亚（UW- 肯尼亚和肯尼亚医学研究所）、南非（金山大学）和秘鲁 （Asociación Civil Selva Amazónica）。国内和国际调查人员都有丰富的经验， 在IND下进行疫苗和其他治疗药物的临床试验，其中许多由NIAID赞助。这 联合体已经证明有能力招募和留住VTEU的目标人群，包括 健康志愿者、孕妇、儿童、患有性传播感染或有感染风险的人，以及 参与人类挑战研究。UW VTEU的具体目标是：1。招聘范围广泛， 经领导小组批准的临床试验参与者; 2.按照以下要求开展临床试验 药物临床试验质量管理规范指南和其他监管指南; 3.确保受试者安全并监督试验 不良事件; 4.支持领导小组制定临床方案，提供独特的 临床和研究实验室能力，进行数据分析，并报告临床试验结果; 5.为希望获得更多信息的早期调查人员提供出色的培训机会和指导 进行临床试验的经验。

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.