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

Recruiting Phase 2 Interventional Study
Human Papilloma Virus Anal Dysplasia HIV
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 70
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
120 (estimated)
Sponsor
University of Maryland, Baltimore · Other
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About This Trial
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 timep…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 18 years old or older and 70 years old or younger * Able to provide informed consent * Denies history of prior HPV vaccination with Gardasil9 (receipt of HPV vaccination other than Gardasil9 such as the bivalent or the quadrivalent HPV vaccine will be allowed) or unsure of vac…
Contacts

Omar Harfouch, MD

410-706-1372

oharfouch@ihv.umaryland.edu

CONTACT

Onyinyechi Ogbumbadiugha-Weekes, MPH

443-635-4943

oogbumbadiugha@ihv.umaryland.edu

CONTACT