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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

February 23, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

January 31, 2026

Conditions
HPV Positive Oropharyngeal Squamous Cell CarcinomaHIV-1-infectionHPV Infection
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

Trial Locations (3)

62209

Instituto Nacional de Salud Pública, Mexico, Cuernavaca

05403-911

Universidade de São Paulo, São Paulo

00935

University of Puerto Rico AIDS Clinical Trials Unit, San Juan

All Listed Sponsors
collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

collaborator

University of Sao Paulo

OTHER

collaborator

University of Puerto Rico

OTHER

collaborator

Instituto Nacional de Salud Publica, Mexico

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

University of California, San Diego

OTHER

lead

Weill Medical College of Cornell University

OTHER

NCT04255849 - Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV | Biotech Hunter | Biotech Hunter