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Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)

Award Number: UM1AR065705
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN 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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DESCRIPTION (provided by applicant): Herpes zoster (HZ), or "shingles", is caused by reactivation of the ubiquitous varicella zoster virus (VZV) that remains latent in sensory neurons following childhood varicella infection ("chickenpox"). It is estimated that one-third of individuas will develop HZ in their lifetime, and that >20% of individuals affected by zoster experience significant morbidity and occasionally mortality. The most common complication is post-herpetic neuralgia, resulting in chronic and sometimes debilitating pain. Other serious complications are rare but devastating, including encephalitis, blindness, loss of hearing and death. HZ risk is elevated by various states of immunosuppression including rheumatoid arthritis (RA), where the risk is approximately double that of the general population. Given the increased HZ disease burden in RA, and the large numbers of RA patients within the US population, prevention of HZ in this setting has major potential public health impact. Currently, a live attenuated vaccine (Zostavax(r)) is available that reduces HZ morbidity by nearly 70%, yet to date, few RA patients have received this vaccine; the Food and Drug Administration (FDA), Center for Disease Control (CDC), and the American College of Rheumatology (ACR) consider the live zoster vaccine contraindicated in patients receiving some immunosuppressive medications such as biologic therapies. This contraindication stems from the theoretical concern that these individuals could develop local or disseminated varicella infection from the vaccine-strain virus. However, there are no published data to suggest that these safety concerns are warranted, and a growing body of observational data suggest that vaccinating such patients might be safe. In light of 1) a substantial elevated HZ risk among RA patients; 2) national data showing most RA patients are not vaccinated for HZ; and 3) the high effectiveness and safety of this vaccine in the general population, we propose to conduct the Varicella zostER VaccinE (VERVE) trial, a randomized, double-blind, placebo-controlled large pragmatic trial to evaluate the immunogenicity, safety, and longer-term effectiveness of the live HZ vaccine in arthritis patients receiving anti-TNF therapy.


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: 2021 ( Subtotal = -$1 )
2021	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	5	2/4/2021	NON-COMPETING CONTINUATION	-$1
														Subtotal = -$1

Issue Date FY: 2019 ( Subtotal = $654,455 )
2019	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	002	5	9/17/2019	NON-COMPETING CONTINUATION	$0
2019	2019	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	5	11/19/2018	NON-COMPETING CONTINUATION	$654,455
2019	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	4	11/19/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $654,455

Issue Date FY: 2018 ( Subtotal = $614,070 )
2018	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	4	5/16/2018	NON-COMPETING CONTINUATION	$61,407
2018	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	4	2/28/2018	NON-COMPETING CONTINUATION	$552,663
2018	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	003	4	9/17/2018	NON-COMPETING CONTINUATION	$0
2018	2016	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	002	3	9/17/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $614,070

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	8/24/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $612,746 )
2016	2016	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	9/2/2016	NON-COMPETING CONTINUATION	$612,746
														Subtotal = $612,746

Issue Date FY: 2015 ( Subtotal = $606,509 )
2015	2015	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	9/7/2015	NON-COMPETING CONTINUATION	$606,509
														Subtotal = $606,509

Issue Date FY: 2014 ( Subtotal = $624,967 )
2014	2014	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	5/19/2014	NEW	$624,967
														Subtotal = $624,967

Grand Total All Awards = $3,112,746

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Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)

Award Number: UM1AR065705

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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