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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06624839
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anal Dysplasia
  • HIV
  • Human Papilloma Virus

Eligibility Criteria

Sex
MALE
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Human papillomavirus (HPV) vaccine, 9-valent — BIOLOGICAL
    0.5 ml intramuscular injection

Study Details

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 Dates

Start date
Mar 15, 2025
Status verified
Apr 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: People born male with current or past exposure to androgen blockers or estrogen (BM-EABE)
    One dose of human papillomavirus (HPV) vaccine, 9-valent (Gardasil9) will be administered on Day 0, Month 2, and Month 6
  • Active Comparator: HIV Negative BM-EABE or HIV Negative men who had sex with a person with a penis (MSPP)
    One dose of human papillomavirus (HPV) vaccine, 9-valent (Gardasil9) will be administered on Day 0, Month 2, and Month 6

Primary Outcome Measure

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 [ Time Frame: 7 months post 1st vaccine dose ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
RIIS Clinic at HIPSWashington D.C.District of Columbia20002-
RIIS Clinic at Baltimore Safe HavenBaltimoreMaryland21201-

Find similar trials in Washington D.C., DC

By condition
HIV
By specialty
Infectious disease
By research site
RIIS Clinic at HIPS· Washington D.C., DCRIIS Clinic at Baltimore Safe Haven· Baltimore, MD

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