Sunday, May 18, 2025 5/18/2025

CoVPN 3006 - A randomized controlled study to assess SARS-CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine

Award Number: UM1AI068635
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 3006 - A randomized controlled study to assess SARS-CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine - Project Abstract This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines Leadership Operations Center (LOC) for implementation of the COVID-19 vaccine trial entitled “A randomized controlled study to assess SARS-CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine.” With the global COVID-19 pandemic, we recognize a significant need for SARS-CoV-2 vaccines that reduce infection in exposed individuals, reduce the amount of viral shedding in infected individuals and reduce transmission from infected individuals to close contacts. Addressing the COVID-19 pandemic, 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. Due to its extensive experience implementing global HIV vaccine trials over the last 20 years, the HIV Vaccine Trials Network (HVTN) LOC was selected as the LOC for CoVPN vaccine trials. This study will monitor the efficacy of the Federal Drug Administration (FDA) Emergency Use Authorized (EUA) Moderna COVID-19 Vaccine to prevent infection in an immediate versus delayed vaccination college student cohort. Participants will be recruited from over 20 universities across the United States and will include three cohorts: 12,000 healthy volunteers aged 18 through 26 years to receive immediate (month 0) or delayed (month 4) vaccination (Main Cohort), up to 24,000 volunteers subject to university SARS-CoV-2 testing who are in close physical proximity with main cohort participants (Prospective Close Contact (PCC) Cohort), and approximately 3 contacts per incidence case for a total of up to 1,500 individuals who have been in close contact with a SARS- CoV-2 positive case from the Main Cohort (Case-Ascertained Close Contact (CACC) Cohort). Participants in the main study will be unblinded to randomization and will be administered vaccine at day 1 (D1) and D29 for the immediate vaccination arm, and at D113 and D141 for the delayed vaccination arm. They will self-collect nasal swabs daily in order to capture all incident SARS-CoVE-2 infection events over 4 months of follow-up and to capture the full course of viral shedding – from onset of infection to viral clearance – among those with both asymptomatic and symptomatic infection. To minimize participant burden and maximize study efficiency many study procedures will occur remotely. SARS-CoV-2 infected participants will complete daily e- diaries to capture symptoms. All trial endpoint assays will be done using qualified and validated assays for diagnosis and immune monitoring and the primary analyses will be conducted among baseline seronegative participants (targeting an entry seropositive rate of < 10%). Specific aims of this study are to assess the clinical efficacy of the Moderna COVID-19 Vaccine to prevent SARS- CoV-2 infection in naïve adults; to evaluate the vaccine effect on peak nasal viral load as a measure of infection and proxy of infectiousness; to evaluate the impact of the vaccine on secondary transmission of SARS-CoV-2 infection; to evaluate vaccine efficacy against COVID-19 disease; and to evaluate the immunogenicity of the vaccine. This trial will add a great deal to our understanding on how effective these vaccines are in reducing and modifying infection as well as preventing transmission to persons living near vaccinated individuals. It will also improve our understanding of the viral dynamics in SARS-CoV-2 mRNA vaccinated individuals. Lastly, the results of this trial will be used to modify future COVID-19 vaccine trials targeting both personal protection and prevention of transmission.


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 = $29,611,681 )
2025	2025	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	20	4/18/2025	NON-COMPETING CONTINUATION	$13,924,806
2025	2025	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	20	12/4/2024	NON-COMPETING CONTINUATION	$16,101,050
2025	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	18	3/26/2025	SUPPLEMENT FOR EXPANSION	$0
2025	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	18	12/17/2024	SUPPLEMENT FOR EXPANSION	$0
2025	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	18	4/7/2025	SUPPLEMENT FOR EXPANSION	$0
2025	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	17	5/5/2025	SUPPLEMENT FOR EXPANSION	-$414,175
														Subtotal = $29,611,681

Issue Date FY: 2024 ( Subtotal = $32,323,449 )
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	19	11/16/2023	NON-COMPETING CONTINUATION	$15,996,245
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	006	19	8/14/2024	NON-COMPETING CONTINUATION	$0
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	19	4/4/2024	NON-COMPETING CONTINUATION	$15,996,243
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	007	19	8/14/2024	SUPPLEMENT FOR EXPANSION	$330,961
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	19	4/18/2024	NON-COMPETING CONTINUATION	$0
2024	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	18	12/1/2023	SUPPLEMENT FOR EXPANSION	$0
2024	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	18	10/25/2023	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	12/1/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $32,323,449

Issue Date FY: 2023 ( Subtotal = $40,855,833 )
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	008	18	3/1/2023	NON-COMPETING CONTINUATION	$26,241,944
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	010	18	6/20/2023	NON-COMPETING CONTINUATION	$2,268,154
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	009	18	5/2/2023	SUPPLEMENT FOR EXPANSION	$12,647,369
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	012	17	9/18/2023	SUPPLEMENT FOR EXPANSION	-$205
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	007	17	2/7/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$6,516,622
2023	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	006	16	2/7/2023	NON-COMPETING CONTINUATION	-$5,436,127
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	003	17	1/11/2023	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	002	16	12/19/2022	NON-COMPETING CONTINUATION	$0
2023	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	001	16	12/13/2022	NON-COMPETING CONTINUATION	$0
2023	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	16	11/30/2022	SUPPLEMENT FOR EXPANSION	-$241,853
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	011	17	9/11/2023	SUPPLEMENT FOR EXPANSION	-$59,576
2023	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	004	14	2/7/2023	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	005	15	2/7/2023	COMPETING CONTINUATION	-$1,080,495
														Subtotal = $40,855,833

Issue Date FY: 2022 ( Subtotal = $48,014,803 ) (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	017	17	6/7/2022	SUPPLEMENT FOR EXPANSION	$318,803
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	016	17	6/6/2022	SUPPLEMENT FOR EXPANSION	$293,711
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	015	17	6/3/2022	SUPPLEMENT FOR EXPANSION	$439,437
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	020	17	6/10/2022	SUPPLEMENT FOR EXPANSION	$419,442
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	018	17	6/8/2022	SUPPLEMENT FOR EXPANSION	$260,795
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	027	17	8/22/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$7,147,272
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	011	17	5/27/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$14,313,000
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	013	17	6/1/2022	SUPPLEMENT FOR EXPANSION	$1,846,794
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	3/29/2022	SUPPLEMENT FOR EXPANSION	$1,334,886
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	014	17	6/2/2022	SUPPLEMENT FOR EXPANSION	$477,868
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	021	17	6/13/2022	SUPPLEMENT FOR EXPANSION	$453,649
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	005	16	3/21/2022	SUPPLEMENT FOR EXPANSION	$818,451
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	028	16	9/19/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	006	16	3/28/2022	SUPPLEMENT FOR EXPANSION	$1,011,819
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	002	16	12/1/2021	NON-COMPETING CONTINUATION	$5,436,127
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	019	17	6/9/2022	SUPPLEMENT FOR EXPANSION	$234,860
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	012	17	5/31/2022	SUPPLEMENT FOR EXPANSION	$14,844,618
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	010	16	5/27/2022	NON-COMPETING CONTINUATION	$0
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	026	15	8/8/2022	SUPPLEMENT FOR EXPANSION	$0
Grand Total All Awards = $340,513,518

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CoVPN 3006 - A randomized controlled study to assess SARS-CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 Vaccine

Award Number: UM1AI068635

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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