# Clinical Trials Program

> **NIH NIH U54** · WEILL MEDICAL COLL OF CORNELL UNIV · 2021 · $1,013,863

## Abstract

Clinical Trials Program Project Summary/Abstract
 The overall goal of the proposal is to advance prevention interventions for HPV-associated cancers
occurring among men and women living with HIV in Latin America and the Caribbean (LAC). We are focusing
on prevention of two HPV-associated cancers, oropharyngeal cancer and cervical cancer. Both cancers are
significantly elevated among individuals living with HIV compared to HIV negative populations and present
prevention, screening, and treatment challenges requiring new solutions.
 To address these significant public health concerns, we will perform the following clinical trials:
1. Investigate immunoprevention of persistent oral HPV infection, a surrogate for prevention of HPV-
 associated OPC, by conducting a double-blind, randomized, placebo-controlled trial of the 9-valent
 HPV vaccine among men living with HIV in Brazil, Mexico and Puerto Rico
2. Evaluate and optimize primary HPV screening with triage to HPV/host DNA methylation for cervical
 cancer screening among women living with HIV
3. Evaluate non-surgical approaches for treating HPV-related cervical pre-cancer by evaluating the
 safety, immunogenicity and preliminary efficacy of a novel HPV therapeutic vaccine, PDS0101, in
 women living with HIV diagnosed with cervical HSIL

## Key facts

- **NIH application ID:** 10232301
- **Project number:** 5U54CA242639-03
- **Recipient organization:** WEILL MEDICAL COLL OF CORNELL UNIV
- **Principal Investigator:** TIMOTHY J. WILKIN
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,013,863
- **Award type:** 5
- **Project period:** 2019-09-20 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10232301

## Citation

> US National Institutes of Health, RePORTER application 10232301, Clinical Trials Program (5U54CA242639-03). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10232301. Licensed CC0.

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