Thursday, March 20, 2025 3/20/2025

CoVPN 3008 Multi-Center, Randomized, Efficacy Study of Early vs Deferred Vaccination with COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern - LC Repository

Award Number: UM1AI068618
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By:

View Award Abstract

The overall goal of the Laboratory Center (LC) is to provide the leadership, structure, oversight and execution of high-quality, state-of-the-art laboratory-based research studies on behalf of the HIV Vaccine Trials Network (HVTN) that will accelerate the development of a safe and efficacious HIV vaccine. Within this framework, the LC will also contribute to developing other strategies to prevent HIV (e.g., immune prophylaxis), as well as to advancing vaccines to prevent M. tuberculosis (Mtb) and other infections of public health importance. For more than a decade, our LC has directed HVTN laboratory studies through the application of innovative science and a rigorous lab quality management program. We have overseen the clinical and largely performed the specialized lab studies globally to broadly define the adaptive, and when relevant, the innate and mucosal immune responses induced by candidate HIV vaccines tested from first-in-human to large-scale efficacy trials. We have determined how prime-boost combinations, delivery route and schedule can impact these responses. The development and use of validated and qualified assays have enabled reliable quantitative assessments and direct comparisons of functions and specificities across different vaccine platforms. This unique capability in the field has informed go/no-go decision-making and prioritization of vaccine candidates and specific regimens to advance to large-scale testing. Our HVTN LC has been at the forefront to define experimentally the correlates of risk and protection induced by vaccination, and potential explanations for failed or modest efficacy in the Step Study, HVTN 505, and the RV144 Thai Trial. The LC is now poised to lead lab investigations in five ongoing global phase 2b/3 HVTN vaccine and HVTN/HPTN immune prophylaxis studies. Through these efforts, the LC has elevated the standards and feasibility of conducting groundbreaking studies in human immunology in the global setting and enriched its science through a wide network of collaborations. Over the next seven years, we propose to build upon and enhance our current scientific and operational infrastructure to execute innovative HVTN studies in a good clinical laboratory practice (GCLP) setting that will provide unambiguous measurements of vaccine immunogenicity, vaccine and monoclonal antibody efficacy and insight into correlates of protection (Aims 1, 3, 4) in adults and children (when indicated). To improve monitoring tools, we will continue to develop, optimize and validate assays that can reveal the broad range and distribution of immune functions that candidate agents elicit and in additional compartments beyond blood (Aims 2, 5). We will embrace collaborations among the larger HIV, TB and immunology fields to enhance these efforts (Aim 6) and will continue to provide leadership and expertise to facilitate investigations with other HIV clinical trials and vaccine networks. Headquartered at FHCRC, the Laboratory Center will integrate its activities seamlessly with the HVTN Leadership and Operations Center and the Statistical and Data Management Center, and cooperatively with the DAIDS Vaccine Clinical Branch.


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 = $14,925,590 )
2025	2025	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	20	11/25/2024	NON-COMPETING CONTINUATION	$15,412,548
2025	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	18	11/26/2024	SUPPLEMENT FOR EXPANSION	$0
2025	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	18	11/27/2024	SUPPLEMENT FOR EXPANSION	$0
2025	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	17	2/13/2025	SUPPLEMENT FOR EXPANSION	-$486,958
														Subtotal = $14,925,590

Issue Date FY: 2024 ( Subtotal = $31,995,055 )
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	19	11/8/2023	NON-COMPETING CONTINUATION	$13,303,754
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	009	19	8/16/2024	SUPPLEMENT FOR EXPANSION	$3,287,548
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	008	19	7/12/2024	NON-COMPETING CONTINUATION	$0
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	007	19	3/20/2024	NON-COMPETING CONTINUATION	$15,403,753
2024	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	006	18	12/11/2023	SUPPLEMENT FOR EXPANSION	$0
2024	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	18	12/11/2023	SUPPLEMENT FOR EXPANSION	$0
2024	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	17	12/11/2023	SUPPLEMENT FOR EXPANSION	$0
2024	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	17	12/4/2023	SUPPLEMENT FOR EXPANSION	$0
2024	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	17	12/11/2023	SUPPLEMENT FOR EXPANSION	$0
2024	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	17	12/11/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $31,995,055

Issue Date FY: 2023 ( Subtotal = $9,679,931 )
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	015	18	4/28/2023	SUPPLEMENT FOR EXPANSION	$1,748,110
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	017	18	5/1/2023	SUPPLEMENT FOR EXPANSION	$3,200,000
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	024	18	7/3/2023	NON-COMPETING CONTINUATION	$5,000,000
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	014	18	3/29/2023	NON-COMPETING CONTINUATION	$17,346,444
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	18	11/21/2022	NON-COMPETING CONTINUATION	$16,063,039
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	17	1/10/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	026	16	7/20/2023	SUPPLEMENT FOR EXPANSION	-$500,081
2023	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	027	16	7/20/2023	SUPPLEMENT FOR EXPANSION	-$49,588
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	012	17	3/24/2023	SUPPLEMENT FOR EXPANSION	-$4,500,000
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	016	17	5/1/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	17	1/10/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	17	1/9/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	010	17	3/23/2023	SUPPLEMENT FOR EXPANSION	-$1,500,000
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	17	1/10/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	009	17	3/23/2023	SUPPLEMENT FOR EXPANSION	-$150,000
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	013	17	3/24/2023	SUPPLEMENT FOR EXPANSION	-$300,000
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	011	17	3/24/2023	SUPPLEMENT FOR EXPANSION	-$300,000
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	008	17	1/11/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	007	17	1/11/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	006	17	1/10/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	17	1/10/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	025	15	7/20/2023	SUPPLEMENT FOR EXPANSION	-$4,166,810
2023	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	023	14	6/21/2023	SUPPLEMENT FOR EXPANSION	-$5,560,116
2023	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	022	14	6/21/2023	SUPPLEMENT FOR EXPANSION	-$16,651,068
														Subtotal = $9,679,931

Issue Date FY: 2022 ( Subtotal = $78,343,151 ) (Continued on the next page)
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	025	17	8/9/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$5,571,540
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	011	17	6/1/2022	SUPPLEMENT FOR EXPANSION	$8,044,100
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	016	17	6/7/2022	SUPPLEMENT FOR EXPANSION	$2,031,957
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	012	17	6/2/2022	SUPPLEMENT FOR EXPANSION	$11,222,643
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	007	16	3/30/2022	SUPPLEMENT FOR EXPANSION	$1,856,516
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	015	17	6/6/2022	SUPPLEMENT FOR EXPANSION	$4,105,979
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	018	17	6/9/2022	SUPPLEMENT FOR EXPANSION	$929,677
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	008	16	5/23/2022	SUPPLEMENT FOR EXPANSION	-$1,856,516
Grand Total All Awards = $405,733,312

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CoVPN 3008 Multi-Center, Randomized, Efficacy Study of Early vs Deferred Vaccination with COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern - LC Repository

Award Number: UM1AI068618

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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