Active — Not RecruitingPhase 3

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

Brazil, Mexico, Puerto Rico700 participantsStarted 2021-02-23

Plain-language 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.

Who can participate

Age range

20 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically for men living with HIV — given my own HIV status and oral HPV history, is this the kind of study my doctor thinks could be relevant to my situation to discuss further?
2Since this is a Phase 3 trial testing the nine-valent HPV vaccine, what does my doctor know about how well this vaccine is already understood to work in people living with HIV compared to the general population?
3The trial is 'active but not recruiting' — does that mean there's any chance of joining, or should I focus on other options right now, like getting the nine-valent HPV vaccine outside of a trial?
4The study is tracking whether the vaccine prevents new persistent oral HPV infections with specific types like 16 and 18 — which are linked to oropharyngeal cancer — so how does my doctor assess my current personal risk for oral HPV and that type of cancer?
5Are there standard-of-care options my doctor would recommend for preventing HPV-related oropharyngeal cancer in someone with my profile, and how do those compare to what this trial is trying to evaluate?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From Month 7 up to Month 60

Trial details

NCT IDNCT04255849

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31

View on ClinicalTrials.gov More HPV Positive Oropharyngeal Squamous Cell Carcinoma trials