Actively Recruiting
Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
Led by University of Maryland, Baltimore · Updated on 2025-05-04
120
Participants Needed
2
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older and 70 years old or younger
- Able to provide informed consent
- Denies history of prior HPV vaccination with Gardasil9 or unsure of vaccination status and born before 2003
- Born Male
- For Test group: HIV-positive people born male with current or past exposure to androgen blockers or estrogen
- Living with HIV
- Current or past exposure to androgen blockers or estradiol
- For Control group: HIV-negative people born male
- HIV negative
- Either: Current or past exposure to androgen blockers or estradiol; or no current or past exposure to androgen blockers or estradiol AND had sex with a person with a penis in the last year
You will not qualify if you...
- Younger than 18 years old or older than 70 years old
- Self-reported or documented history of nine-valent HPV vaccine or unsure of vaccination status and born after 2003
- Born female
- History of severe allergic reactions to yeast or other vaccine components
- Any condition requiring systemic chemotherapy, immunomodulatory treatment, or immunoglobulin supplementation within the previous 6 months (precancerous lesions not exclusionary)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
RIIS Clinic at HIPS
Washington D.C., District of Columbia, United States, 20002
Not Yet Recruiting
2
RIIS Clinic at Baltimore Safe Haven
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
O
Omar Harfouch, MD
CONTACT
O
Onyinyechi Ogbumbadiugha-Weekes, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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