Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
University of Maryland, Baltimore · NCT06624839
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–70 · Men only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 2
- Target enrollment
- 120
- US sites recruiting
- 1
- Study start
- March 15, 2025
- Record last updated
- August 5, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: Human papillomavirus (HPV) vaccine, 9-valent
Conditions: Human Papilloma Virus; Anal Dysplasia; HIV
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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).
Recruiting US locations
RIIS Clinic at Baltimore Safe Haven
Baltimore, MD 21201
Study contacts (from the official record)
- Omar Harfouch, MD · 410-706-1372 · oharfouch@ihv.umaryland.edu
- Onyinyechi Ogbumbadiugha-Weekes, MPH · 443-635-4943 · oogbumbadiugha@ihv.umaryland.edu
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