Wednesday, April 2, 2025 4/2/2025

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 GY18

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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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 GY18 - 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 efficacy trial, CoVPN 3008 (the Ubuntu study) entitled “Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS- CoV-2 Variants of Concern.” As the global COVID-19 pandemic has persisted, it has become clear not only that there are great risks faced by people who are immunocompromised, but also that there is an urgent need to better understand infection and disease in these populations so we can prevent severe COVID-19 as well as chronic SARS-CoV-2 infections that could promote transmission and the emergence of new, dangerous variants. This is particularly true for the over 37 million people living with HIV (PLWH) who are concentrated in sub-Saharan Africa and have been significantly underrepresented in COVID-19 vaccine trials. This novel study aims to address critical knowledge gaps by evaluating COVID-19 mRNA vaccine efficacy among PLWH, including the influence of prior infection and degree of immunocompromise. This multicenter trial comparing different regimens of the Moderna mRNA-1273 and mRNA-1273.222 vaccines will test the efficacy of the vaccines in preventing COVID-19 disease regardless of severity, and in preventing COVID-19 severe disease, in people who are at risk for symptomatic and severe COVID-19 in areas of the world where the prevalence of SARS-CoV-2 Variants of Concern is substantial. This is the first large scale study evaluating the effectiveness of mRNA vaccines against symptomatic and severe COVID-19 among PLWH. In this study, at Month 0 (enrollment) all participants will receive a 100-mcg dose of mRNA-1273. At Month 1, all participants without evidence of prior SARS-CoV-2 infection at baseline (based on serology) will receive a second dose of mRNA-1273. At Month 6, all participants (regardless of baseline SARS- CoV-2 status) will receive a 100-mcg dose of either mRNA-1273 or mRNA-1273.222, depending on their randomization at enrollment. All trial endpoint assays will be done using qualified and validated assays for diagnosis and immune monitoring. The follow up of this study is divided into two stages: Pre-Month 6 stage (visits up to and including Month 6) and post-Month 6 stage (visits through to Month 12). This allows a timely evaluation of the pre-Month 6 study objectives as soon as Month 6 diagnostic data are available without the need to wait until the end of Month 12 follow up. Specific aims of this study pertaining to both pre- and post-Month 6 stages are to assess the relative risk of symptomatic and severe COVID-19 after the first vaccine dose at Month 0 through to Month 6 in PLWH who are SARS-CoV-2 negative at baseline who receive a 2-dose mRNA-1273 vaccine regimen vs. in PLWH who are SARS-CoV-2 positive at baseline who receive a 1-dose mRNA-1273 regimen, as well as to assess this relative risk for complete follow-up through to Month 12. Specific aims of this study pertaining to the post-Month 6 stage are to assess the relative risk of symptomatic and severe COVID-19 after the Month 6 dose through to Month 12 among those who received mRNA-1273 at Month 6 vs. those who received mRNA-1273.222 at Month 6. Additionally, this study will assess safety and tolerability of mRNA-1273 and mRNA-1273.222 in PLWH and adults who are at risk of severe COVID-19 in both the pre-Month 6 and post-Month 6 stages. The study will also seek to characterize SARS-CoV-2 nucleic acid amplification test (NAAT) persistence, viral shedding and the evolution of viral mutations among participants who acquire SARS-CoV-2 infection. By collecting efficacy and safety data in over half-a-dozen countries across sub-Saharan Africa, the study team hopes to inform regulators in the region and help facilitate access to mRNA vaccine technology across Africa. Importantly, the study will also assess both cellular and an


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	005	18	3/25/2025	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	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	004	18	3/25/2025	SUPPLEMENT FOR EXPANSION	$0
2025	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	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	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	007	19	3/20/2024	NON-COMPETING CONTINUATION	$15,403,753
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	000	19	11/8/2023	NON-COMPETING CONTINUATION	$13,303,754
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	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	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	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
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
														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	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	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	000	18	11/21/2022	NON-COMPETING CONTINUATION	$16,063,039
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	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	002	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	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	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	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 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	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	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	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	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	026	17	8/23/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$9,691,804
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	019	16	6/17/2022	NON-COMPETING CONTINUATION	$0
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	017	17	6/8/2022	SUPPLEMENT FOR EXPANSION	$1,227,287
2022	2022	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	024	16	8/9/2022	NON-COMPETING CONTINUATION	-$4,367,621
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	009	17	5/27/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$21,176,541
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 GY18

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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