Phase 2 Study of Gardasil 9-Valent HPV Vaccine Immune Responses in People Born Male With and Without HIV and Hormone Exposure

What this Trial Is About

Researchers are evaluating the immune response to the FDA-approved 9-valent human papillomavirus HPV recombinant vaccine, Gardasil9, in people born male who currently or previously used androgen blockers or estrogen. This phase 2, open-label study includes participants with HIV and HIV-negative controls who are either similarly exposed or men who have sex with a person with a penis. The study aims to compare vaccine responses between these groups to better understand immunity and potential prevention in this population. Participants will receive three doses of Gardasil9 vaccine at Day 0, Month 2, and Month 6. Before vaccination, participants provide blood samples and anal swabs to evaluate HPV immunity, anal HPV presence, and anal dysplasia. After the final vaccine dose, blood samples and anal swabs will be collected again at Month 7 to assess immune responses. Participants with HPV16 or anal dysplasia on cytology will undergo clinical referral for further examination and possible biopsy, with optional follow-up visits for additional sampling. During the study, participants will attend visits for vaccine administration and sample collection at specified timepoints. Researchers will analyze humoral and cellular immune responses, comparing results pre- and post-vaccination as well as between participants with different HIV status and hormone exposure. Safety and clinical management of anal dysplasia will be monitored. The study will continue through early 2028, with the primary immune response evaluated one month after the last vaccine dose.

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