🏛️ Verified NIH Record • Updated 2026-06-16

Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV (NCT04255849)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Weill Medical College of Cornell University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (8 items).

Location: Universidade de São Paulo — São Paulo, São Paulo

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Have a history of oropharyngeal cancer (OPC) or other HPV-related cancer or have suspected OPC or other HPV-related cancer;
  • Have received any doses of a licensed or experimental HPV vaccine or have participated in an HPV vaccine study,
  • Have a history of anaphylaxis to vaccines or are allergic to any vaccine component (e.g.aluminum, yeast, benzonase);
  • Have received any blood products within six months of enrollment, or are currently taking immune-suppressants.
  • Currently have warts/lesions in the oral cavity.
  • Plan to relocate during the study period.
  • Have AIDS-defining condition within 6 months prior to study entry.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

  • Universidade de São Paulo — São Paulo, São Paulo
  • Instituto Nacional de Salud Pública, Mexico — Cuernavaca, Morelos
  • University of Puerto Rico AIDS Clinical Trials Unit — San Juan, Purto Rico

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗