# Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site

> **NIH NIH UM1** · UNIVERSITY OF MARYLAND BALTIMORE · 2022 · $2,098,592

## Abstract

Project Summary/Abstract
The University of Maryland School of Medicine (UMSOM) Center for Vaccine Development and Global Health
(CVD) has been an established VTEU site since 1974. The goal of the VTEUs is to initiate innovative concepts
for clinical research and implement clinical site protocols for evaluating vaccines, other preventive biologics,
therapeutics, diagnostics, and devices for the treatment and prevention of infectious diseases, and CVD is
uniquely poised to accomplish this goal. CVD's expert and accomplished investigative team has
complementary skill sets in all areas necessary to address the NIAID priority areas, with established
management plans to effectively allocate work and conduct multiple projects simultaneously. CVD is
internationally recognized for our capacity and capability to conduct controlled human infection trials for
malaria, influenza, and enteric pathogens and to implement treatment and prevention trials in endemic areas
for malaria and neglected tropical diseases (NTD), both of which have been a focus of its research for many
years. CVD has access to U.S. populations of healthy subjects in all age groups for this research and subjects
with special risks, such as patients attending outpatient clinics with sexually transmitted infection (STI) and
other conditions that generally do not requiring hospitalization. Strong domestic collaborations at sites
experienced in clinical trials provide the CVD's VTEU with surge capacity among healthy subjects of all ages
and vulnerable populations such as pregnant women in the U.S. to address public health emergencies. CVD's
international collaborators, including two long-standing permanent field sites in Africa, are an invaluable
resource for vetted international trial sites in low resource countries endemic for malaria and NTD with
experience in conducting high quality NIAID and VTEU studies. This proposal describes mechanisms to
implement protocols that arise from concepts proposed by the Leadership Group (LG) and the research
community including investigators from other VTEUs, academia, industry, non-governmental organizations,
and DMID. These concepts will focus on NIAID priority areas, including malaria, NTD, respiratory infections,
particularly influenza, enteric diseases, STI, and emerging infectious diseases and other infectious disease
considerations. Under our VTEU contract that is nearing completion (2013-2023), CVD was awarded over 23
Task Orders, enrolled over 1,500 participants, and successfully collaborated with national and international
sites. This renewal application is intended to supplement the new VTEU award (1UM1AI148689) that we
received in December, 2019 in response to AI18-046; funding for this award was limited to one year as a result
of an omission by our Sponsored Programs Administration to include a request for 7 full years of funding. The
current proposal seeks to supplement that one year award with an additional 6 years of funding.

## Key facts

- **NIH application ID:** 10493529
- **Project number:** 3UM1AI148689-03S3
- **Recipient organization:** UNIVERSITY OF MARYLAND BALTIMORE
- **Principal Investigator:** Karen L. Kotloff
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $2,098,592
- **Award type:** 3
- **Project period:** 2021-05-28 → 2024-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10493529

## Citation

> US National Institutes of Health, RePORTER application 10493529, Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site (3UM1AI148689-03S3). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10493529. Licensed CC0.

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