University of Washington Vaccine and Treatment Evaluation Unit

拟议的华盛顿大学(UW)疫苗和治疗评估股(VTEU)将由 在国内和国际临床试验中经验丰富的研究人员，并由方向盘支持 委员会，包括本应用程序重点领域的主要专家，包括呼吸系统 传染病、性传播感染、疟疾挑战研究、肠道感染和其他被忽视的疾病 热带病。联合首席调查员已经进行了30项临床试验，其中大多数是在IND；这些 包括由NIAID赞助试验，包括VTEU合同、HPTN和STI CTG、行业赞助商以及 调查员持有的工业拟建的港景医疗中心VTEU研究诊所已被 进行了几十年的临床试验，以及招募、登记和保留实践和 政策已经制定得很好了。我们在获得研究资金方面的良好记录导致了威斯康星大学 医学院提供了专门为容纳临床试验而设计的充足空间 在传染病领域进行的研究。UW VTEU将利用非凡的广度和深度 UW的专业知识、设施、资源、人口和地理覆盖范围以及我们的合作 机构。在当地，这些机构包括西雅图儿童医院和弗雷德·哈钦森癌症研究中心， 除了威斯康星大学医学院的几个校园地点。在国际上，包括UW在内的调查人员 VTEU还领导着在肯尼亚拥有出色基础设施的成熟和经验丰富的研究站点(UW- 肯尼亚和肯尼亚医学研究所)、南非(威特沃特斯兰德大学)和秘鲁 (美国公民协会Selva Amazónica)。国内和国际调查人员都有丰富的经验 在IND的指导下进行疫苗和其他疗法的临床试验，许多试验由NIAID赞助。这 财团已证明有能力招募和留住VTEU目标人群，包括 健康志愿者、孕妇、儿童、性传播感染高危人群，以及 人类挑战研究的参与者。UW VTEU的具体目标是：1.招募广泛的 参加领导小组批准的临床试验；2.按照规定实施临床试验 良好的临床实践指南和其他监管指南；3.确保参与者的安全并监督试验 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.为希望获得成功的早期调查人员提供出色的培训机会和指导 有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.