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

Study acronym: PROTECT
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 2025 to Mar 15, 2025
    v4
  3. Enrollment target: 180 to 120v3 Show 6 more changesShow less
    • Primary endpoint revised
    • Start date: Feb 2025 to Mar 2025
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints revised (7)
    • Study description expanded, about 15 words
    • Study title expanded, about 1 word
  4. Start date: Oct 2024 to Feb 2025v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06624839
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)		 Human Papilloma Virus, Anal Dysplasia, HIV
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov