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
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).
Description
This will be a phase 2, open-label study to assess the humoral and cellular immune response to the FDA-approved 9-valent HPV recombinant vaccine in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). At baseline, BM-EABE with HIV, HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) will provide blood samples and anal swabs for evaluation of HPV immunity, anal HPV and anal dysplasia. All participants will undergo a 3-dose vaccine series of the Gardasil vaccine (at Day 0, Month 2 and Month 6). Participants will then return…
Eligibility
- Age range
- 18–70 years
- Sex
- Male
- Healthy volunteers
- Yes
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 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 (BM-EABE) * Living with HIV * Current or past exposure to androgen blockers or estradiol For Control group: HIV-negative Control * HIV neg…
Interventions
- BiologicalHuman papillomavirus (HPV) vaccine, 9-valent
0.5 ml intramuscular injection
Locations (2)
- RIIS Clinic at HIPSWashington D.C., District of Columbia
- RIIS Clinic at Baltimore Safe HavenBaltimore, Maryland