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Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
Sponsor: University of Maryland, Baltimore
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).
Official title: 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
Key Details
Gender
MALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-03-15
Completion Date
2028-01
Last Updated
2025-05-04
Healthy Volunteers
Yes
Conditions
Interventions
Human 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