RecruitingPhase 2NCT06624839

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

A PRe-pOsT Interventional Study Evaluating Gardasil Nine-valent Human Papilloma Virus (HPV) Vaccine Humoral and Cellular Immune Responses in People With or Without HIV


Sponsor

University of Maryland, Baltimore

Enrollment

120 participants

Start Date

Mar 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how the Gardasil 9 HPV vaccine works in people with and without HIV, specifically in individuals who were born male and may have used hormone therapy. Researchers want to understand whether HIV status or hormone exposure affects how the body responds to the HPV vaccine. **You may be eligible if...** - You were born male and are between 18 and 70 years old - You have never received the Gardasil 9 HPV vaccine (or are unsure and were born before 2003) - You are living with HIV and have used androgen blockers or estrogen (past or present), OR - You are HIV-negative and have had sex with a person with a penis in the past year, or have used hormone therapy **You may NOT be eligible if...** - You were born female - You have already received the Gardasil 9 HPV vaccine (and were born after 2003) - You have had a severe allergic reaction to yeast or vaccine ingredients - You are currently receiving chemotherapy, immunotherapy, IV immunoglobulin, or radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHuman papillomavirus (HPV) vaccine, 9-valent

0.5 ml intramuscular injection


Locations(2)

RIIS Clinic at HIPS

Washington D.C., District of Columbia, United States

RIIS Clinic at Baltimore Safe Haven

Baltimore, Maryland, United States

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NCT06624839


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