NCT06624839 Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
| NCT ID | NCT06624839 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Human Papilloma Virus |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-03-15 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-03-15 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil9) in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). Investigators will enroll BM-EABE with HIV and HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) and administer Gardasil9 at timepoints Day 0, Month 2, and Month 6. The immune response to the vaccine will be analyzed at Month 7 (1 month following the final vaccine dose).
Eligibility Criteria
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).
Contact & Investigator
Omar Harfouch, MD
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT06624839 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 70 Years, studying Human Papilloma Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06624839 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06624839 currently recruiting?
Yes, NCT06624839 is actively recruiting participants. Contact the research team at oharfouch@ihv.umaryland.edu for enrollment information.
Where is the NCT06624839 trial being conducted?
This trial is being conducted at Washington D.C., United States, Baltimore, United States.
Who is sponsoring the NCT06624839 clinical trial?
NCT06624839 is sponsored by University of Maryland, Baltimore. The principal investigator is Omar Harfouch, MD at University of Maryland, Baltimore. The trial plans to enroll 120 participants.