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RECRUITING
NCT06624839
PHASE2

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

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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