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Therapeutic use of HPV L1 Vaccine in Anogenital Neoplasia: VIVA Trial

Award Number: R01CA213130
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/22/2017
PERIOD OF PERFORMANCE END DATE: 01/31/2024

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Therapeutic use of HPV L1 Vaccine in Anogenital Neoplasia: VIVA Trial - PROJECT SUMMARY Anal and vulvar high-grade intraepithelial lesions (AIN3/VIN3) often recur after primary treatment, with 30% local recurrence or progression in the 5-years following treatment. Surgeries for recurrence can be debilitating and associated with compromised quality of life. Most AIN3/VIN3 (>90%) are associated with human papillomavirus (HPV), and emerging data suggest a therapeutic use of the licensed prophylactic HPV vaccine may reduce risk of recurrence. The licensure trials showed that the HPV vaccine prevents AIN3/VIN3 among women who were HPV negative (uninfected) at vaccination. We propose a randomized, double-blind, placebo- controlled trial to test whether the 9-valent HPV vaccine (Gardasil 9) will reduce recurrence in previously unvaccinated persons treated for AIN3/VIN3. A non-randomized study suggested that recurrence following surgical treatment for AIN2/3 was reduced by 50% by HPV vaccination. In addition, our pilot study showed that recurrence after VIN3 was less likely among HPV16 antibody positive women compared to those without an HPV16 antibody response (hazard ratio (HR) 0.4, 95% CI 0.2-0.9) among unvaccinated women. Based on prior studies and our pilot data, we hypothesize that the high burden of recurrence of AIN3/VIN3 could be reduced 50% by vaccination. Following primary surgical treatment, we will randomize 345 patients with AIN3/VIN3 to receive 9-valent Gardasil or placebo. The primary endpoint is the efficacy of the vaccine against biopsy-documented recurrence. The study, called the HPV Vaccine to Interrupt Progression of Vulvar and Anal Lesions Trial (the VIVA Trial), will also evaluate the safety of the vaccine in the study population. The VIVA trial includes centralized pathology review of initial and recurrent lesions and active surveillance for recurrence during study visits over 3 years. Secondary endpoints will explore etiologic questions to assess whether persistence of HPV infection and HPV antibodies are associated with recurrence; these data could eventually add importantly to selection of individual patients for closer monitoring or more aggressive treatment. Our scientific team has extensive expertise in conducting vaccine trials, conducting HPV surveillance and histopathology, and performing HPV laboratory assays. The designated study pathologist will evaluate all study biopsies to assess recurrence status. This will be the first US-based trial of the concept and, if it is successful, could lead to changes in practice, as administration of the licensed HPV vaccine would be a low-cost additional treatment for AIN3/VIN3.


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 = -$20,826 )
2024	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	000	6	6/11/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$20,826
														Subtotal = -$20,826

Issue Date FY: 2022 ( Subtotal = $780,737 )
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	004	6	8/2/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$57,512
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	002	6	6/9/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$780,737
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	000	5	1/26/2022	NON-COMPETING CONTINUATION	$0
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	003	5	8/2/2022	NON-COMPETING CONTINUATION	-$57,512
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	001	5	6/9/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $780,737

Issue Date FY: 2021 ( Subtotal = $227,161 )
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	000	5	2/25/2021	NON-COMPETING CONTINUATION	$227,161
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	001	5	3/18/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $227,161

Issue Date FY: 2020 ( Subtotal = $1,151,093 )
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	002	4	8/31/2020	SUPPLEMENT FOR EXPANSION	$145,995
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	003	4	9/2/2020	SUPPLEMENT FOR EXPANSION	$105,379
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	001	4	4/28/2020	SUPPLEMENT FOR EXPANSION	$134,231
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	000	4	2/24/2020	NON-COMPETING CONTINUATION	$765,488
														Subtotal = $1,151,093

Issue Date FY: 2019 ( Subtotal = $815,931 )
2019	2019	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	001	3	1/31/2019	SUPPLEMENT FOR EXPANSION	$108,522
2019	2019	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	000	3	1/30/2019	NON-COMPETING CONTINUATION	$707,409
														Subtotal = $815,931

Issue Date FY: 2018 ( Subtotal = $841,469 )
2018	2018	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	000	2	1/12/2018	NON-COMPETING CONTINUATION	$656,495
2018	2018	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	001	2	5/23/2018	NON-COMPETING CONTINUATION	$72,943
2018	2018	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	002	2	8/31/2018	NON-COMPETING CONTINUATION	$23,882
2018	2018	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	003	2	9/18/2018	SUPPLEMENT FOR EXPANSION	$88,149
														Subtotal = $841,469

Issue Date FY: 2017 ( Subtotal = $767,849 )
2017	2017	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Cause and Prevention Research	000	1	2/22/2017	NEW	$767,849
														Subtotal = $767,849

Grand Total All Awards = $4,563,414

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Therapeutic use of HPV L1 Vaccine in Anogenital Neoplasia: VIVA Trial

Award Number: R01CA213130

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/22/2017

PERIOD OF PERFORMANCE END DATE: 01/31/2024

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