NCT04255849

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

Active, enrolled Phase 3 Last updated 23 January 2026

What this trial tests

Phase 3 trial testing 9 valent human papillomavirus vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) in HPV Positive Oropharyngeal Squamous Cell Carcinoma in 700 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

23 February 2021

Primary endpoint
1 May 2026

1 July 2026

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	700
Start date	23 February 2021
Primary completion	1 May 2026
Estimated completion	1 July 2026
Sites	3 locations across Puerto Rico, Brazil, Mexico

Drugs / interventions tested

• 9 valent human papillomavirus vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) — full drug profile →
• Saline Placebo

Conditions studied

• HPV Positive Oropharyngeal Squamous Cell Carcinoma — all drugs for HPV Positive Oropharyngeal Squamous Cell Carcinoma →
• HIV-1-infection — all drugs for HIV-1-infection →
• HPV Infection — all drugs for HPV Infection →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 20 to 50, male only, with HPV Positive Oropharyngeal Squamous Cell Carcinoma or HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cervical cancer prevention and control in women living with human immunodeficiency virus.
   Castle PE, Einstein MH, Sahasrabuddhe VV. · · 2021 · cited 160× · PMID 34499351 · DOI 10.3322/caac.21696
2. The effect of non-AIDS-defining cancers on people living with HIV.
   Chiao EY, Coghill A, Kizub D, Fink V, et al · · 2021 · cited 60× · PMID 34087151 · DOI 10.1016/s1470-2045(21)00137-6
3. Current status and future directions for the development of human papillomavirus vaccines.
   Wang R, Huang H, Yu C, Li X, et al · · 2024 · cited 36× · PMID 38983849 · DOI 10.3389/fimmu.2024.1362770
4. Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies.
   Giuliano AR, Palefsky JM, Goldstone SE, Bornstein J, et al · · 2025 · cited 3× · PMID 39840832 · DOI 10.1080/21645515.2024.2425146
5. State-of-the-Science of human papillomavirus vaccination in women with human immunodeficiency Virus: Summary of a scientific workshop.
   Schuind AE, Rees H, Schiller J, Mugo N, et al · · 2023 · cited 3× · PMID 37576844 · DOI 10.1016/j.pmedr.2023.102331
6. 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.
   Giuliano AR, Beltrame A, Villa LL, Lazcano-Ponce E, et al · · 2025 · cited 2× · PMID 40609265 · DOI 10.1016/j.vaccine.2025.127447
7. Alcohol consumption and oral human papillomavirus infection among men living with HIV: a cross-sectional study from the ULACNet 201 trial.
   Beltrame A, Villa LL, Lazcano-Ponce E, Santana-Bagur J, et al · · 2026 · PMID 42215629 · DOI 10.1038/s41598-026-55676-6
8. Clinical research progress and challenges of vaccine for human papillomavirus-associated cancers.
   Xue L, Li X, Guo X, Xing H, et al · · 2026 · PMID 42179134 · DOI 10.1080/21645515.2026.2676391