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) 疫苗和治疗评估单位 (VTEU) 将由 国内和国际临床试验经验丰富的研究人员，并得到指导的支持 委员会包括本应用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疾病 热带疾病。联合首席研究员已进行超过 30 项临床试验，其中大部分处于 IND 阶段；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 研究者进行的 IND。拟议的 VTEU 研究诊所位于 Harborview 医疗中心 进行了数十年的临床试验，以及招募、入组和保留实践， 政策已经制定得很完善。我们在获得研究经费方面的良好记录导致了威斯康星大学 医学院提供充足的空间，专为容纳临床试验而设计 在传染病领域进行。威斯康星大学 VTEU 将利用其非凡的广度和深度 威斯康星大学和我们的合作伙伴的专业知识、设施、资源、人口和地理范围 机构。在当地，这些机构包括西雅图儿童医院和 Fred Hutchinson 癌症研究中心， 除了威斯康星大学医学院的几个校区外。在国际上，研究人员包括在华盛顿大学 VTEU 还在肯尼亚（威斯康星大学- 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 （亚马逊民间塞尔瓦协会）。国内外研究者在这方面都拥有丰富的经验 根据 IND 进行疫苗和其他疗法的临床试验，其中许多试验由 NIAID 赞助。这 财团已展示出招募和留住 VTEU 目标人群的能力，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 人类挑战研究的参与者。威斯康星大学 VTEU 的具体目标是： 1. 广泛招募 领导小组批准的临床试验参与者； 2、按照规定实施临床试验 良好临床实践指南和其他监管指南； 3. 确保参与者的安全并监控试验 对于不良事件； 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. 为希望获得成果的早期研究人员提供出色的培训机会和指导 进行临床试验的经验。