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

> **NIH NIH R01** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2020 · $134,231

## Abstract

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.

## Key facts

- **NIH application ID:** 10098635
- **Project number:** 3R01CA213130-04S1
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** MARGARET M MADELEINE
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $134,231
- **Award type:** 3
- **Project period:** 2017-02-22 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10098635

## Citation

> US National Institutes of Health, RePORTER application 10098635, Therapeutic use of HPV L1 Vaccine in Anogenital Neoplasia: VIVA Trial (3R01CA213130-04S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10098635. Licensed CC0.

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