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Can the HPV vaccine fully protect transgender women and people with HIV?

NCT ID NCT06624839

Vaccine Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study is testing how well the 9-valent HPV vaccine (Gardasil9) triggers an immune response in people born male who have used estrogen or androgen blockers, including those living with HIV. Participants receive three doses of the vaccine over six months, and their immune response is measured one month after the final dose. The goal is to see if the vaccine works as well in these groups as it does in others, potentially improving protection against HPV-related cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
9-valent human papillomavirus (HPV) vaccine (Gardasil9)
What this could lead to
If successful, this could confirm that the HPV vaccine works well in transgender women and people with HIV, potentially improving protection against HPV-related cancers in these groups.
What could go wrong
This is a phase 2 trial with a relatively small number of participants, so results may not apply to everyone. The immune response may vary, and the study does not directly measure cancer prevention.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

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

Started

Mar 2025

Expected to finish

Jan 2028

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

18 to 70 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * 18 years old or older and 70 years old or younger * Able to provide informed consent * Denies history of prior HPV vaccination with Gardasil9 (receipt of HPV vaccination other than Gardasil9 such as the bivalent or the quadrivalent HPV vaccine will be allowed) or unsure of vaccination status and born before 2003 * Born Male For Test group: HIV-positive people born male with current or past exposure to androgen blockers or estrogen (BM-EABE) * Living with HIV * Current or past exposure to androgen blockers or estradiol For Control group: HIV-negative Control * HIV negative * Either: Current or past exposure to androgen blockers or estradiol; no current or past exposure to androgen blockers or estradiol AND had sex with a person with a penis in the last year Exclusion Criteria: * Younger than 18 years old or older than 70 years old. * Self-reported or documented history of nine-valent HPV vaccine or unsure of vaccination status and born after 2003. * Born female * History of hypersensitivity, including severe reactions to yeast or other component of the vaccine. * Any condition requiring systemic chemotherapy or immunomodulant affecting antibody responses (i.e., rituximab, ibrutinib etc.), intravenous or subcutaneous immunoglobulin supplementation, radiation therapy, or immunomodulatory treatment within the previous 6 months (presence of precancerous lesions is not exclusionary).

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Conditions

The condition(s) this trial relates to.

HIV infectious disease human papilloma virus infection prevention target

As listed by the trial registrant

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

Anal dysplasia HIV Human papilloma virus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • RIIS Clinic at Baltimore Safe Haven

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • RIIS Clinic at HIPS

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20002, United States

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