HPVPhase 4HPVacNCT06588257
Acceptability of the HPV Vaccine and Anal HPV in Transgender Women and Men Who Have Sex With Men: A Pilot Study
A Phase 4 study testing Non-infectious adjuvanted recombinant nonavalent HPV vaccine in people with HPV, run by Fundación Huésped at 1 site in Argentina.
Trial summary
Protocol Title: "Acceptability of the Human Papillomavirus (HPV) Vaccine and Anal HPV in Transgender Women (TGW) and Men Who Have Sex with Men (MSM): A Pilot Study. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HPV
- What is being tested?
- Non-infectious adjuvanted recombinant nonavalent HPV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteArgentina
- Study dates
- 9 Oct 2024to 4 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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
- CD4 cell count ≥ 200 cells/ml in the last 6 months (participant can bring a laboratory report from the last 6 months)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Fundación Huésped
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1427CEA
About this study
Official title: Acceptability of the Human Papillomavirus (HPV) Vaccine and Anal HPV in Transgender Women (TGW) and Men Who Have Sex With Men (MSM): A Pilot Study
Protocol Title: "Acceptability of the Human Papillomavirus (HPV) Vaccine and Anal HPV in Transgender Women (TGW) and Men Who Have Sex with Men (MSM): A Pilot Study.
Read the detailed description
Protocol Number: FH-79
Study Objetives:
- Evaluate the acceptability, uptake, and completion of HPV vaccination.
- Determine the baseline prevalence (before HPV vaccination) and incidence of vaccine-specific genotypes of nonavalent HPV in the anus (anatomical site) after vaccination.
- Determine the initial prevalence (before HPV vaccination) and incidence of anal cytological lesions after HPV vaccination.-
- Determine the initial prevalence (before HPV vaccination) and incidence of oral and anogenital lesions associated with HPV, according to physical examination, after HPV vaccination.
- Analyze barriers and facilitators to the acceptability, uptake, and completion of HPV vaccination from the perspective of MSM and TGW.
Patient Population: MSM (men who have sex with men) and TGW (transgender woman)
Study design: Phase IV. Longitudinal and prospective study for which a cohort of 100 MSM (men who have sex with men)and TGW (transgender woman) will be formed at Fundación Huésped. Pilot study of mixed quantitative and qualitative methodology.
Regimens: Non-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0, 2, 6 months). (Trade name GARDASIL 9 -MSD), Duration: 12 months
Sample size: 105 subjects
- Conditions
- HPV
- Being tested
- Non-infectious adjuvanted recombinant nonavalent HPV vaccine
- Keywords
- HPV, MSM, TGW, Acceptability, vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-infectious adjuvanted recombinant nonavalent HPV vaccineBiological
Non-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0, 2, 6 months). (Trade name GARDASIL 9 -MSD).
| Study group | Role | What they receive |
|---|---|---|
| Men who have sex with men with HIV | Other | Evaluate the acceptability, uptake, and completion of HPV vaccination. Receives: Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccine |
| Transgender women with HIV | Other | Evaluate the acceptability, uptake, and completion of HPV vaccination. Receives: Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccine |
| Men who have sex with men without HIV | Other | Evaluate the acceptability, uptake, and completion of HPV vaccination. Receives: Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccine |
| Transgender women without HIV | Other | Evaluate the acceptability, uptake, and completion of HPV vaccination. Receives: Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of people receiving the first dose of vaccine and of people receiving 3 doses of HPV vaccine among those recruited.
To evaluate uptake HPV vaccination, the proportion of who receiving the first dose of HPV vaccine among those who have entered the study will be estimated, and to assess HPV vaccination completion, the proportion of who receiving three doses of HPV vaccine among those enrolled will be estimated.
Measured: 12 months
Secondary outcomes (2)
Frequency of anal HPV genotypes
To determine the prevalence and incidence of anal HPV genotypes (considering the genotypes in the nonavalent vaccine), HPV genotype from anal samples will be performed to determine the frequency of anal HPV at baseline (day 1), month 6 and month 12.
Measured: 12 months
Frequency of anal HPV related cytologic lesions
To determine the prevalence and incidence of anal HPV-associated cytological lesions, anal cytology will be performed to determine the frequency of anal HPV associated cytological lesions at baseline (day 1), month 6 and month 12.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Oct 2024
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A pilot study of mixed quantitative and qualitative methodology is proposed. A prospective cohort of 100 men who have sex with men and transgender women, with and without HIV will be organized at Fundación Huésped to study acceptability of HPV vaccine and effect of HPV vaccine on anal HPV infection. Moreover, 20 people from the cohort along with 5 additional people who shall not agree to receive the HPV vaccine will participate in in depth interviews. (qualitative component).
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Huésped
- Sponsor type
- University, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Responsible party
- Principal investigator, FLORENCIA MARINA CAHN, Fundación Huésped
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588257
- Sponsor's protocol ID
- FH-79
- Acronym
- HPVac
- Status last verified
- May 2026
- First submitted
- 29 Aug 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be shared upon request, 6 months after last patient´s last visit. URL not yet available.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of the Human Papillomavirus (HPV) Vaccine and Anal HPV in Transgender Women (TGW) and Men Who Have Sex With Men (MSM): A Pilot Study
- ClinicalTrials.gov ID
- NCT06588257
- Acronym / sponsor ID
- HPVac / FH-79
- Conditions
- HPV
- Keywords
- HPV, MSM, TGW, Acceptability, vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Fundación HuéspedUniversity, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protocol Title: "Acceptability of the Human Papillomavirus (HPV) Vaccine and Anal HPV in Transgender Women (TGW) and Men Who Have Sex with Men (MSM): A Pilot Study.
Detailed description
Protocol Number: FH-79
Study Objetives:
- Evaluate the acceptability, uptake, and completion of HPV vaccination.
- Determine the baseline prevalence (before HPV vaccination) and incidence of vaccine-specific genotypes of nonavalent HPV in the anus (anatomical site) after vaccination.
- Determine the initial prevalence (before HPV vaccination) and incidence of anal cytological lesions after HPV vaccination.-
- Determine the initial prevalence (before HPV vaccination) and incidence of oral and anogenital lesions associated with HPV, according to physical examination, after HPV vaccination.
- Analyze barriers and facilitators to the acceptability, uptake, and completion of HPV vaccination from the perspective of MSM and TGW.
Patient Population: MSM (men who have sex with men) and TGW (transgender woman)
Study design: Phase IV. Longitudinal and prospective study for which a cohort of 100 MSM (men who have sex with men)and TGW (transgender woman) will be formed at Fundación Huésped. Pilot study of mixed quantitative and qualitative methodology.
Regimens: Non-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0, 2, 6 months). (Trade name GARDASIL 9 -MSD), Duration: 12 months
Sample size: 105 subjects
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A pilot study of mixed quantitative and qualitative methodology is proposed. A prospective cohort of 100 men who have sex with men and transgender women, with and without HIV will be organized at Fundación Huésped to study acceptability of HPV vaccine and effect of HPV vaccine on anal HPV infection. Moreover, 20 people from the cohort along with 5 additional people who shall not agree to receive the HPV vaccine will participate in in depth interviews. (qualitative component).
| Arm | Type | Receives |
|---|---|---|
| Men who have sex with men with HIV | Other | Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccineEvaluate the acceptability, uptake, and completion of HPV vaccination. |
| Transgender women with HIV | Other | Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccineEvaluate the acceptability, uptake, and completion of HPV vaccination. |
| Men who have sex with men without HIV | Other | Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccineEvaluate the acceptability, uptake, and completion of HPV vaccination. |
| Transgender women without HIV | Other | Biological: Non-infectious adjuvanted recombinant nonavalent HPV vaccineEvaluate the acceptability, uptake, and completion of HPV vaccination. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-infectious adjuvanted recombinant nonavalent HPV vaccineNon-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0, 2, 6 months). (Trade name GARDASIL 9 -MSD). | Biological | Men who have sex with men with HIV, Men who have sex with men without HIV, Transgender women with HIV, Transgender women without HIV |
Primary outcome
Proportion of people receiving the first dose of vaccine and of people receiving 3 doses of HPV vaccine among those recruited.
Time frame: 12 months
To evaluate uptake HPV vaccination, the proportion of who receiving the first dose of HPV vaccine among those who have entered the study will be estimated, and to assess HPV vaccination completion, the proportion of who receiving three doses of HPV vaccine among those enrolled will be estimated.
2 secondary outcomes
Frequency of anal HPV genotypes
Time frame: 12 months
Frequency of anal HPV related cytologic lesions
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided. It will be shared upon request, 6 months after last patient´s last visit. URL not yet available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-infectious adjuvanted recombinant nonavalent HPV vaccine in people with HPV, run by Fundación Huésped at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of people receiving the first dose of vaccine and of people receiving 3 doses of HPV vaccine among those recruited. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.