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Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site

Award Number: UM1AI148689
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/11/2019
PERIOD OF PERFORMANCE END DATE: 11/30/2026

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Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $1,515,427 )
2025	2025	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	6	12/11/2024	NON-COMPETING CONTINUATION	$1,515,427
														Subtotal = $1,515,427

Issue Date FY: 2024 ( Subtotal = $1,752,798 )
2024	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	006	5	6/11/2024	NON-COMPETING CONTINUATION	$61,796
2024	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	007	5	7/16/2024	NON-COMPETING CONTINUATION	$0
2024	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	001	5	11/16/2023	NON-COMPETING CONTINUATION	$1,691,002
2024	2022	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	3	10/12/2023	SUPPLEMENT FOR EXPANSION	$0
2024	2022	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	005	3	2/23/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2022	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	002	3	2/21/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2022	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	004	3	2/22/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2022	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	003	3	2/22/2024	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $1,752,798

Issue Date FY: 2023 ( Subtotal = $3,268,655 )
2023	2023	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	4	12/9/2022	NON-COMPETING CONTINUATION	$3,268,655
2023	2023	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	009	4	8/4/2023	NON-COMPETING CONTINUATION	$0
2023	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	001	3	2/10/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	007	3	4/28/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	006	3	4/28/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	003	3	2/10/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	002	3	2/10/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	004	3	2/28/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	008	3	5/31/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	005	3	4/28/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $3,268,655

Issue Date FY: 2022 ( Subtotal = $13,582,683 ) (Continued on the next page)
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	020	3	5/13/2022	SUPPLEMENT FOR EXPANSION	$1,818,913
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	026	3	8/25/2022	SUPPLEMENT FOR EXPANSION	$1,382,804
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	006	3	3/10/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	002	3	2/3/2022	SUPPLEMENT FOR EXPANSION	$563,973
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	024	3	8/23/2022	SUPPLEMENT FOR EXPANSION	$169,734
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	013	3	5/6/2022	SUPPLEMENT FOR EXPANSION	$2,098,592
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	022	3	5/24/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	023	3	8/22/2022	SUPPLEMENT FOR EXPANSION	$1,813,428
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	001	3	2/1/2022	SUPPLEMENT FOR EXPANSION	$298,077
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	021	3	5/23/2022	NON-COMPETING CONTINUATION	$0
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	005	3	3/10/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	3	1/7/2022	NON-COMPETING CONTINUATION	$3,959,354
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	025	3	8/24/2022	SUPPLEMENT FOR EXPANSION	$1,188,978
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	029	2	9/14/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	010	2	4/28/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	015	2	5/13/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	016	2	5/13/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	014	2	5/13/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	018	2	5/13/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	012	2	5/6/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	028	2	9/14/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	019	2	5/13/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	027	2	9/14/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	017	2	5/13/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2020	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	003	1	2/22/2022	SUPPLEMENT FOR EXPANSION	$265,757
2022	2020	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	007	1	3/29/2022	SUPPLEMENT FOR EXPANSION	$265,757
2022	2020	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	008	1	4/1/2022	NEW	$23,073
Grand Total All Awards = $50,766,188

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Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site

Award Number: UM1AI148689

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/11/2019

PERIOD OF PERFORMANCE END DATE: 11/30/2026

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