# University of Washington Vaccine and Treatment Evaluation Unit

> **NIH NIH UM1** · UNIVERSITY OF WASHINGTON · 2020 · $9,616,028

## Abstract

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.

## Key facts

- **NIH application ID:** 10120765
- **Project number:** 3UM1AI148573-01S1
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Helen Ying-hui Chu
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $9,616,028
- **Award type:** 3
- **Project period:** 2020-03-12 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10120765

## Citation

> US National Institutes of Health, RePORTER application 10120765, University of Washington Vaccine and Treatment Evaluation Unit (3UM1AI148573-01S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10120765. Licensed CC0.

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