Friday, April 19, 2024 4/19/2024

CoVPN 3008, Multi-Center, Randomized, Efficay Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern

Award Number: UM1AI068619
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By Issue Date FY or Funding FY:

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PROJECT SUMMARY The overarching goal of the HIV Prevention Trials Network (HPTN) is to identify acceptable, feasible, safe, effective and scalable interventions for HIV prevention that address the needs of populations at risk in the U.S. and around the world. The HPTN will address this goal by identifying: 1) new biomedical products and tools for HIV prevention that have unique characteristics, such as longer duration of action, new targets for inhibition of HIV replication, or as multipurpose prevention technologies (MPTs); and (2) integrated strategies that optimize use of proven efficacious prevention interventions and new tools tailored to specific populations at risk to achieve maximal public health impact. These interventions will be evaluated in priority populations for HIV prevention including women in sub-Saharan Africa, young men and women at risk, men who have sex with men (MSM), transgender women (TGW) who have sex with men, female sex workers (FSW) and persons who inject drugs (PWID). The specific aims of this research will be 1) To design and conduct studies of long-acting antiretroviral (ARV) agents and delivery systems for pre-exposure prophylaxis (PrEP); 2) To design and conduct studies to evaluate MPTs that concurrently prevent HIV and pregnancy, sexually transmitted infections (STIs) or opioid dependence; 3) To design and conduct studies in collaboration with the HIV Vaccine Trials Network to evaluate broadly neutralizing antibodies (bnAbs), alone and in combination, for PrEP; 4) To design and conduct integrated strategies for HIV prevention. For the first three aims, the HPTN will use a sequential multi-phase drug development strategy for the evaluation of new candidates for prevention. Phase 1 and 2 studies will be conducted for the evaluation of appropriate dose, safety and tolerability of the agent(s). The most promising systemic agents will be advanced using the criteria for a favorable target product profile for new agents including highly effective and durable protection against HIV, minimal adverse effects and drug interactions, high levels of user acceptability, and a high barrier to viral resistance. Efficacious biomedical prevention interventions will be incorporated into integrated strategy study designs that also include socio- behavioral interventions tailored to the HIV prevention imperatives and contextual needs of the specific populations at risk for HIV infection. Socio-Behavioral research (SBR) will be integral to the success of all aspects of the proposed HPTN HIV prevention agenda. Supportive SBR will be used to strengthen biomedical HIV product development (i.e. to inform user preference and ultimately product design for Phase 1-3 clinical trials), while integrative SBR will play a key role in the process of designing and adapting behavioral and structural interventions to complement biomedical interventions in integrated strategy studies. The HPTN will design and conduct the research through collaboration with its scientific leadership, its research teams, community partners, research participants, pharmaceutical companies and funders.


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: 2024 ( Subtotal = $13,098,494 )
2024	2024	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	002	18	3/6/2024	NON-COMPETING CONTINUATION	$2,840,970
2024	2024	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	000	18	11/21/2023	NON-COMPETING CONTINUATION	$10,257,524
2024	2023	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	001	17	11/30/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $13,098,494

Issue Date FY: 2023 ( Subtotal = -$2,829,465 )
2023	2023	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	000	17	11/21/2022	NON-COMPETING CONTINUATION	$14,186,117
2023	2023	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	003	17	3/8/2023	NON-COMPETING CONTINUATION	$8,133,330
2023	2023	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	007	17	8/17/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2023	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	006	17	5/24/2023	SUPPLEMENT FOR EXPANSION	$1,007,764
2023	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	004	15	4/7/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	005	15	5/24/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	001	15	1/27/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	002	14	2/7/2023	SUPPLEMENT FOR EXPANSION	-$26,156,676
														Subtotal = -$2,829,465

Issue Date FY: 2022 ( Subtotal = $39,020,844 )
2022	2022	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	003	16	7/20/2022	NON-COMPETING CONTINUATION	$14,296,763
2022	2022	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	004	16	8/24/2022	NON-COMPETING CONTINUATION	$1,454,590
2022	2022	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	001	16	11/24/2021	NON-COMPETING CONTINUATION	$23,269,491
2022	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	000	15	11/23/2021	SUPPLEMENT FOR EXPANSION	$0
2022	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	002	15	11/24/2021	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $39,020,844

Issue Date FY: 2021 ( Subtotal = $100,363,565 )
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	006	15	4/26/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	001	15	12/21/2020	SUPPLEMENT FOR EXPANSION	$8,980,894
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	009	15	8/19/2021	SUPPLEMENT FOR EXPANSION	$8,797,243
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	000	15	11/17/2020	COMPETING CONTINUATION	$21,418,133
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	010	15	9/3/2021	COMPETING CONTINUATION	$27,624,911
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	007	15	7/27/2021	COMPETING CONTINUATION	$18,134,934
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	002	15	3/19/2021	COMPETING CONTINUATION	$3,129,793
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	012	15	9/8/2021	COMPETING CONTINUATION	$10,431,422
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	004	15	4/12/2021	SUPPLEMENT FOR EXPANSION	$75,740,362
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	008	15	7/29/2021	SUPPLEMENT FOR EXPANSION	$12,277,657
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	005	15	4/12/2021	SUPPLEMENT FOR EXPANSION	$24,021,991
2021	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	011	14	9/7/2021	NON-COMPETING CONTINUATION	-$10,431,422
2021	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	003	14	4/12/2021	SUPPLEMENT FOR EXPANSION	-$99,762,353
														Subtotal = $100,363,565

Issue Date FY: 2020 ( Subtotal = $216,243,558 )
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	007	14	8/7/2020	SUPPLEMENT FOR EXPANSION	$16,951,807
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	010	14	8/24/2020	SUPPLEMENT FOR EXPANSION	$1,403,811
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	009	14	8/18/2020	SUPPLEMENT FOR EXPANSION	$24,427,777
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	006	14	8/3/2020	SUPPLEMENT FOR EXPANSION	$9,589,068
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	004	14	7/17/2020	SUPPLEMENT FOR EXPANSION	$47,540,164
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	013	14	9/15/2020	SUPPLEMENT FOR EXPANSION	$24,714,967
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	001	14	3/10/2020	NON-COMPETING CONTINUATION	$8,092,990
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	012	14	9/9/2020	SUPPLEMENT FOR EXPANSION	$17,834,622
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	003	14	7/13/2020	SUPPLEMENT FOR EXPANSION	$9,822,578
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	005	14	7/27/2020	SUPPLEMENT FOR EXPANSION	$615,715
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	011	14	8/26/2020	NON-COMPETING CONTINUATION	$22,282,543
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	002	14	5/22/2020	NON-COMPETING CONTINUATION	$6,900,627
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	008	14	8/12/2020	SUPPLEMENT FOR EXPANSION	$16,687,150
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	000	14	11/19/2019	NON-COMPETING CONTINUATION	$9,379,739
														Subtotal = $216,243,558

Issue Date FY: 2019 ( Subtotal = $42,425,177 ) (Continued on the next page)
2019	2019	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	002	13	5/13/2019	NON-COMPETING CONTINUATION	$11,214,124
Grand Total All Awards = $695,800,388

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CoVPN 3008, Multi-Center, Randomized, Efficay Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern

Award Number: UM1AI068619

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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