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Clinical Trial NCT04255849 for HPV Positive Oropharyngeal Squamous Cell Carcinoma, HIV-1-infection, HPV Infection is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV Phase 3 700 Vaccine Study Randomized Double-Blind Placebo-Controlled

Active, not recruiting
Clinical Trial NCT04255849 is designed to study Prevention for HPV Positive Oropharyngeal Squamous Cell Carcinoma, HIV-1-infection, HPV Infection. It is a Phase 3 interventional study that is active, not recruiting, having started on 23 February 2021, with plans to enroll 700 participants. Led by Weill Medical College of Cornell University, it is expected to complete by 1 July 2026. The latest data from ClinicalTrials.gov was last updated on 23 January 2026.
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.
Detailed Description
Men ages 20-50 years living with HIV will be enrolled at affiliated clinical sites of the University of Puerto Rico, the National Institute of Public Health, Mexico, and University of São Paulo, Brazil. Participants will have a baseline blood draw for serum HPV antibodies and stored plasma, an oral rinse for HPV testing, HPV methylation, and EBV co-infection, stored anal and genital samples for HPV testing, as well a...Show More
Official Title

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

Conditions
HPV Positive Oropharyngeal Squamous Cell CarcinomaHIV-1-infectionHPV Infection
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
NCT ID Number
NCT04255849
Start Date (Actual)
2021-02-23
Last Update Posted
2026-01-23
Completion Date (Estimated)
2026-07-01
Enrollment (Estimated)
700
Study Type
Interventional
PHASE
Phase 3
Status
Active, not recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimental9-valent HPV vaccine
Participants receive 9-valent HPV vaccine 0.5mL at entry, Month 2 and Month 6
9 valent human papillomavirus vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)
Gardasil-9 HPV vaccine
Placebo ComparatorSaline Placebo
Participants receive 0.9% NaCl 0.5 mL at entry, Month 2 and Month 6
Saline Placebo
Saline Placebo
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Immunogenicity of 9-valent HPV vaccine as measured by proportion of participants experiencing seroconversion for vaccine type.
To evaluate our secondary immunogenicity endpoint, we will assess the proportion of men who seroconvert to the HPV vaccine types 6, 11, 16, 18, 31, 33, 45, 52, or 58 (both in grouped and type-specific analyses) in serum one month post-dose three (Month 7) using the Wilson's method. Men who enter the study seronegative for a particular HPV vaccine type will be monitored for seroconversion following three doses of 9vHPV.
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.
To evaluate the secondary safety and tolerability endpoint, we will report the proportion of participants experiencing a grade 3 or 4 adverse event at least possibly related to study vaccine, grade 1 or 2 adverse events leading to premature discontinuation of vaccine or placebo, and serious adverse events.
Baseline through Month 7
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
20 Years
Eligible Sexes
Male
  • 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.

  • 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.
Weill Medical College of Cornell University logoWeill Medical College of Cornell University
No contact data.
3 Study Locations in 3 Countries

São Paulo

Universidade de São Paulo, São Paulo, São Paulo, 05403-911, Brazil

Morelos

Instituto Nacional de Salud Pública, Mexico, Cuernavaca, Morelos, 62209, Mexico

Purto Rico

University of Puerto Rico AIDS Clinical Trials Unit, San Juan, Purto Rico, 00935, Puerto Rico