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

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 one month after completion of third vaccine (Month 7) to provide repeat blood samples and anal swabs. Samples will be compared pre and post vaccination and in-between participants based on HIV and exposure to androgen blockers or estrogen (EABE).

Any participant with human papillomavirus 16 (HPV16) and/or anal dysplasia on anal cytology at any point will be referred to high-resolution anoscopy (HRA) for clinical management. Anal biopsies will be procured from different pathology laboratories - after clinical evaluation has been complete - for research analysis, including confocal microscopy. Those who had anal dysplasia at study entry will undergo repeat HRA, as clinically indicated, and will have an optional study visit following their repeat HRA to provide blood draw and anal swabs.

• Compare the humoral immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls [Срок оценки: 7 months post 1st vaccine dose]
• Compare the humoral immune response to Gardasil9 between BM-EABE (regardless of HIV status) and BM without EABE (people born male without current or past exposure to androgen blockers or estrogen) [Срок оценки: 7 months post 1st vaccine dose]
• Evaluate the systemic HPV T-cell immune response to Gardasil9 in HIV positive BM-EABE and HIV negative controls. [Срок оценки: 7 months post 1st vaccine dose]
• Compare systemic HPV T-cell immune response to Gardasil9 between HIV positive BM-EABE and HIV negative controls. [Срок оценки: 7 months post 1st vaccine dose]
• Compare systemic HPV T-cell immune response to Gardasil9 between BM-EABE (regardless of HIV status) and BM without EABE. [Срок оценки: 7 months post 1st vaccine dose]
• Evaluate the impact of HPV vaccination on HIV reservoir in CD4 T cells of BM-EABE with HIV. [Срок оценки: Before vaccination, 7 months post 1st dose]
• Compare humoral immune response to Gardasil9 between different subset populations from PROTECT (HIV positive BM-EABE , HIV negative BM-EABE , and HIV negative MSPP), to age-matched historical controls. [Срок оценки: 7 months post 1st vaccine dose]