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CoVPN 3008 - Multi-Center, Randomized, Efficacy 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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CoVPN 3008 - Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern - This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) for implementation of the COVID-19 vaccine efficacy trial entitled “Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern.” With the global COVID-19 pandemic, we recognize a significant need for vaccines that modify COVID-19 in SARS-CoV-2 infected individuals. Addressing this gap, the National Institutes of Health (NIH) led rapid constitution of the CoVPN, partnering 5 NIH supported clinical trial networks, to create an enhanced network of physician-scientists at 145 United States (US) and 71 international clinical trial sites in 17 countries dedicated to developing globally effective vaccines for SARS-CoV-2. This Phase 3, observer-blinded, placebo-controlled, crossover-vaccination study will test the efficacy of the COVID-19 ancestral strain mRNA vaccine in preventing COVID-19 disease regardless of severity, and preventing COVID-19 severe disease in people who are at risk for severe COVID-19 in areas of the world where the prevalence of the SARS-CoV-2 1.351 strain is substantial. The trial has been designed to provide as rapid assessment of efficacy as possible in regions of the world where local access to effective vaccines are limited. Subjects will be randomized in a 1:1 ratio to receive immediate or deferred vaccine. The blinded cross-over is expected to take place when vaccine benefit is declared based on at least 50 primary COVID-19 endpoints, anticipated to be accrued approximately 3 months post-trial start. All trial endpoint assays will be done using qualified and validated assays for diagnosis and immune monitoring. Specific aims of this study are to demonstrate efficacy of COVID-19 mRNA (Moderna mRNA-1273) vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19; to assess vaccine efficacy of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19; and to assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19. This efficacy trial will tell us much about ability of an mRNA vaccine against the ancestral Wuhan strain of SARS- CoV-2 to protect individuals exposed to divergent strains, and in particular 1.351 first predominant in South Africa. In addition, it will improve our understanding of the dynamics and duration of these immune responses and will inform rational design and testing of preventive and therapeutic monoclonal antibody interventions in parts of the world where alternative strains continue to proliferate. Lastly, the results of this trial will be used to assess registration of this vaccine product as well as to modify future COVID-19 vaccine trials planned over the next 12 months.


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 = -$28,758,942 )
2025	2025	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	003	19	4/15/2025	NON-COMPETING CONTINUATION	$9,802,411
2025	2025	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	001	19	11/25/2024	NON-COMPETING CONTINUATION	$15,627,262
2025	2023	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	005	17	5/13/2025	SUPPLEMENT FOR EXPANSION	-$1,007,764
2025	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	004	15	5/13/2025	SUPPLEMENT FOR EXPANSION	-$7,779,478
2025	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	002	15	3/19/2025	SUPPLEMENT FOR EXPANSION	-$44,188,335
2025	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	000	14	10/1/2024	NON-COMPETING CONTINUATION	-$1,213,038
														Subtotal = -$28,758,942

Issue Date FY: 2024 ( Subtotal = $25,449,117 )
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	2024	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Allergy and Infectious Diseases Research	003	18	6/6/2024	NON-COMPETING CONTINUATION	$12,350,623
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 = $25,449,117

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	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	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	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	001	15	1/27/2023	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	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 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	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	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
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
														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	005	15	4/12/2021	SUPPLEMENT FOR EXPANSION	$24,021,991
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	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	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	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	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	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	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	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	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	002	15	3/19/2021	COMPETING CONTINUATION	$3,129,793
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
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
														Subtotal = $100,363,565

Issue Date FY: 2020 ( Subtotal = $216,243,558 ) (Continued on the next page)
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	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	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	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	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	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	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	000	14	11/19/2019	NON-COMPETING CONTINUATION	$9,379,739
Grand Total All Awards = $679,392,069

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CoVPN 3008 - Multi-Center, Randomized, Efficacy 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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