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

Phase 3 Active not recruiting 700 enrolled Weill Medical College of Cornell University H. Lee Moffitt Cancer Center and Research Institute · collab Instituto Nacional de Salud Publica, Mexico · collab Merck Sharp & Dohme LLC · collab National Cancer Institute (NCI) · collab University of California, San Diego · collab University of Puerto Rico · collab University of Sao Paulo · collab

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2021-02-23
Primary completion: 2026-07-31
Completion: 2026-07-31

Publications

Giuliano AR, Beltrame A, Villa LL, Lazcano-Ponce E, Santana-Bagur J, Allen-Leigh B, Portillo-Romero AJ, Sahasrabuddhe VV, House MG, Brofsky E, Galan de Paula L, Carvalho da Silva R, Schell MJ, Rathwell J, Isaacs-Soriano K, Fan W, Mello C, Ellsworth GB, Wilkin T. Design of a multicenter, randomized, double-blinded, placebo-controlled phase III trial evaluating the 9-valent human papillomavirus (HPV) vaccine to prevent persistent oral HPV infection in men living with human immunodeficiency virus: ULACNet trial 201. Vaccine. 2025 Aug 13;61:127447. doi: 10.1016/j.vaccine.2025.127447. Epub 2025 Jul 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	9 valent human papillomavirus vaccine	Vaccine	0.5 ml	—

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

Summary

Timeline

Publications

Drugs

Indications