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HPV vaccine pilot shows promise for High-Risk groups

NCT ID NCT06588257

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed pilot study enrolled 101 transgender women and men who have sex with men to see how acceptable the HPV vaccine (Gardasil 9) is in these groups. Participants received three doses over six months, and researchers tracked how many completed the series and how common anal HPV infections were. The goal is to improve vaccine uptake and reduce 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
HPV vaccine (Gardasil 9)
What this could lead to
If successful, this could help improve HPV vaccination rates and reduce anal cancer risk in these groups.
What could go wrong
This is a small, completed pilot study focused on acceptability, not on proving the vaccine prevents disease. Results may not apply to broader populations.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

101 people

The number who actually took part.

Started

Oct 2024

Finished

May 2026

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 90 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: * Accept participation in the study by signing informed consent * Age ≥18 years old * People who consider themselves men who have sex with men or transgender women * All eligible people with HIV must meet the following: 1. stable antiretroviral treatment during the last 6 months and with undetectable viral load (depending on the method used for measurement) within the same period (the participant can bring a laboratory report carried out in the last 6 months). Regarding ART, a change associated with toxicity or simplification may be allowed before 12 weeks of the selection visit, with undetectable VL between 12 weeks and the selection visit; and 2. CD4 cell count ≥ 200 cells/ml in the last 6 months (participant can bring a laboratory report from the last 6 months) Exclusion Criteria: * Have a history or current suspicion of cancer * Have a known history or current suspicion of high-grade lesion or anal intraepithelial neoplasia related to HPV. * Have received any dose of HPV vaccine at some time in your life. * Have received any vaccine in the last 30 days. * Have a known allergy to any of the components of the HPV vaccine. * Have a history of a previous severe allergic reaction, regardless of the cause. * Presenting an acute illness that could alter the study evaluations or could put the participant at risk, according to the researcher\'s criteria. * Present chronic or acute immunosuppression (except HIV). * Have received antineoplastic and immunomodulatory agents or radiotherapy in the 6 months prior to the study or plan to receive these treatments during the study period. * Having chronic diseases without adequate control. * Have a diagnosis of ongoing malignant disease. * Having received immunoglobulins, blood or blood products in the last 3 months. * Do not participate in another intervention study * That he is not an employee or first-degree relative of any member of the institution. * Any condition or clinical situation where it is considered that participation in the study may pose a risk to the patient.\* \* People with chronic HBV infection, who are receiving treatment and have normal transaminases for the last 6 months can be included in the study. People with chronic HCV infection can enter the study if they have normal transaminases for the last 6 months and do not plan to start treatment during the study. In either case, transaminases can be requested through the study if they are not available.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Fundación Huésped

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1427CEA, Argentina

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