Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site

The University of Maryland School of Medicine (UMSOM) Center for Vaccine Development and Global Health (CVD) has been an established VTEU site since 1974. 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 the 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 the 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 was 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 the 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.

Study type: Interventional
Enrollment: 65 participants
Primary purpose: Prevention
Allocation:Non-Randomized
Interventional Model: Sequential assignment
Masking: Open label
NCT number: NCT03589794
Phase: Phase I

Project detailsClinical Trial.gov details

Combination of Interventions
Leadership & Governance

Dec 2019 — Nov 2026

$47.5M

United States