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University of Washington Vaccine and Treatment Evaluation Unit

华盛顿大学疫苗和治疗评估单位

基本信息

批准号：
10120765
负责人：
Helen Ying-hui Chu
金额：
$ 961.6万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-03-12 至 2023-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10120765
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&apos 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

项目摘要

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.

拟议中的华盛顿大学（UW）疫苗和治疗评估股（VTEU）将由