Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-70
SponsorUniversity of Maryland, Baltimore
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 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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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 hypersensitivity, including severe reactions to yeast or other component of the vaccine.
Trial design
Treatments tested in this trial
- Human papillomavirus (HPV) vaccine, 9-valent
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov