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Gardasil HPV Vaccine Study in People Born Male With and Without HIV

This study is looking at how well the Gardasil9 vaccine works in people born male, specifically those who have used or are currently using androgen blockers or estrogen (BM-EABE), with and without HIV. Researchers want to see the immune response (how your body fights off infection) to the vaccine. The study will give three doses of the Gardasil9 vaccine over six months. Success for this study means seeing a good immune response to the vaccine seven months after the first dose. The study plans to enroll 120 participants, but its current status is unclear.

Study design
This is a Phase 2, open-label study, meaning you and the researchers will know which treatment you are receiving. It plans to enroll 120 participants.
What's involved
You would receive three doses of the Gardasil9 vaccine over six months. You would also provide blood samples and anal swabs at the beginning of the study and one month after your last vaccine dose.
Compensation
Not stated in the trial record.
Follow-up
Your immune response will be analyzed seven months after your first vaccine dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06624839

Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV

Recruiting
PHASE2Ages 18–70InterventionalPrevention
University of Maryland, Baltimore
~120 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Human papillomavirus (HPV) vaccine, 9-valent

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Immunogenicity of the human papillomavirus (HPV) vaccine in BM-EABE (people born male with current or past exposure to androgen blockers or estrogen (BM-EABE) with and without HIV
Measured over 7 months post 1st vaccine dose

Conditions

Human Papilloma Virus
Anal Dysplasia
HIV

Explore related trials

Anal Intraepithelial NeoplasiaHIV InfectionHuman Papillomavirus InfectionHIV Infection

Where it's being run

2 sites across 2 states
District of Columbia1
Maryland1

Study leadership

  • Omar Harfouch, MD · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore

Who to contact

Omar Harfouch, MD
[email protected]
410-706-1372
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Living with HIV
Current or past exposure to androgen blockers or estradiol
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

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).

What this trial measures

  • Immunogenicity of the human papillomavirus (HPV) vaccine in BM-EABE (people born male with current or past exposure to androgen blockers or estrogen (BM-EABE) with and without HIV7 months post 1st vaccine dose

    Proportion of BM-EABE who become seropositive or have an increase in their GMT by \>25% to at least 1 homologous HPV vaccine genotype at 1 month following the 3rd dose of the vaccine.