NCT04255849

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for phase_3

Timeline
2mo left

Started Feb 2021

Longer than P75 for phase_3

Geographic Reach
3 countries

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Feb 2021Jul 2026

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5.2 years

First QC Date

January 31, 2020

Last Update Submit

January 22, 2026

Conditions

HPV Positive Oropharyngeal Squamous Cell CarcinomaHIV-1-infectionHPV Infection

Outcome Measures

Primary Outcomes (1)

  • Number of participants with new persistent oral HPV infections with one or more of the following types: 6, 11, 16, 18, 31, 33, 45, 52, or 58

    The primary endpoint is incident persistent oral HPV infection with HPV types 6, 11, 16, 18, 31, 33, 45, 52, or 58 occurring among participants who remain oral HPV negative to the relevant HPV type through the vaccination period (Day 1-Month 6). Newly acquired oral HPV infections that persist for two or more consecutive oral HPV assessments at least 16 weeks apart with the same 9vHPV detected are defined as "persistent". Case counting will commence with the Month 7 clinical visit and may occur at any timepoint through the final visit.

    From Month 7 up to Month 60

Secondary Outcomes (2)

  • Immunogenicity of 9-valent HPV vaccine as measured by proportion of participants experiencing seroconversion for vaccine type.

    Month 7

  • Safety and tolerability of 9-valent HPV vaccine as measured by proportion of participants with >= grade 3 adverse events related to study vaccination or Grade 1 or 2 events leading to premature discontinuation of vaccination, or serious adverse events.

    Baseline through Month 7

Study Arms (2)

9-valent HPV vaccine

EXPERIMENTAL

Participants receive 9-valent HPV vaccine 0.5mL at entry, Month 2 and Month 6

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

Saline Placebo

PLACEBO COMPARATOR

Participants receive 0.9% NaCl 0.5 mL at entry, Month 2 and Month 6

Other: Saline Placebo

Interventions

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

Gardasil-9 HPV vaccine

9-valent HPV vaccine
Saline PlaceboOTHER

Saline Placebo

Saline Placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV-1 infection
  • Receipt of antiretroviral therapy for at least 6 months
  • Sexually active in the past 6 months; sexual activity is defined as insertive penile-vaginal sex, receptive or insertive penile-anal sex, oral-anal sex, or oral-genital sex Willingness to comply with three-dose vaccine schedule and subsequent six-month visits for up to four years after randomization.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universidade de São Paulo

São Paulo, São Paulo, 05403-911, Brazil

Location

Instituto Nacional de Salud Pública, Mexico

Cuernavaca, Morelos, 62209, Mexico

Location

University of Puerto Rico AIDS Clinical Trials Unit

San Juan, Purto Rico, 00935, Puerto Rico

Location

Related Publications (1)

  • 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.

    PMID: 40609265DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Grant Ellsworth, MD, MS

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

February 23, 2021

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie results in the publication, after deidentification

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months following publication and available through period of funding of ULACNet (U54 CA242639).
Access Criteria
Researchers who provide a methodologically sound proposal for use of the data that is approved by the study investigators and the sponsor. The research must be broadly consistent with that of ULACNet. Researchers may submit a request to the study principal investigator (Grant Ellsworth gre9006@med.cornell.edu) to request details of request format.

Locations

BR(1)ME(1)PR(1)