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Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV

NCT04255849 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-01-23

No results posted yet for this study

Summary

This is a randomized, double-blinded, placebo-controlled Phase III interventional trial of the nine-valent HPV vaccine (9vHPV) to prevent persistent oral HPV infection in adult men living with HIV.

Conditions

Interventions

BIOLOGICAL

9 valent human papillomavirus vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)

Gardasil-9 HPV vaccine

OTHER

Saline Placebo

Saline Placebo

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • University of Sao Paulo

    collaborator OTHER

  • University of Puerto Rico

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • University of California, San Diego

    collaborator OTHER

  • Instituto Nacional de Salud Publica, Mexico

    collaborator OTHER

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Grant Ellsworth, MD, MS · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2026-05-01
Completion
2026-07-01
FDA Drug
Yes

Countries

  • Brazil
  • Mexico
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04255849 on ClinicalTrials.gov