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Can a vaccine stop oral HPV in men with HIV?

NCT ID NCT04255849

Prevention Sponsor: Weill Medical College of Cornell University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study tests whether the nine-valent HPV vaccine can prevent long-lasting oral HPV infections in men who have HIV. About 700 men will receive either the vaccine or a placebo. The goal is to see if the vaccine reduces new persistent infections with HPV types linked to throat cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 50 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease oropharynx squamous cell carcinoma human papilloma virus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection HPV infection HPV positive oropharyngeal squamous cell carcinoma

Contacts and locations

Locations

  • Instituto Nacional de Salud Pública, Mexico

    Cuernavaca, Morelos, 62209, Mexico

  • Universidade de São Paulo

    São Paulo, São Paulo, 05403-911, Brazil

  • University of Puerto Rico AIDS Clinical Trials Unit

    San Juan, Purto Rico, 00935, Puerto Rico

More trials for these conditions

Other studies related to the condition(s) this trial covers.