University of Washington Vaccine and Treatment Evaluation Unit

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.