HPV vaccine pilot shows promise for High-Risk groups
NCT ID NCT06588257
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
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Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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