Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
Recruiting now · Phase 2
Conditions studied: Human Papilloma Virus, Anal Dysplasia, HIV
In brief
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).
Key facts
- Study ID
- NCT06624839
- Run by
- University of Maryland, Baltimore
- People needed
- 120
- Starts
- 2025-03-15
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older, up to 70. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- RIIS Clinic at Baltimore Safe Haven — Baltimore, Maryland, United States (enrolling)
- RIIS Clinic at HIPS — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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