A Phase 2 Open-Label Study Evaluating Gardasil Nine-valent HPV Vaccine Immune Responses in People Born Male With or Without HIV

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 have current or past exposure to androgen blockers or estrogen (BM-EABE). This phase 2, open-label study includes participants with and without HIV and aims to assess both humoral and cellular immunity to the vaccine. The study also examines anal HPV infection and anal dysplasia among participants. Participants will receive three doses of the Gardasil9 vaccine administered intramuscularly on Day 0, Month 2, and Month 6. Blood samples and anal swabs will be collected at the start and one month after the final vaccine dose (Month 7) to evaluate immune responses and HPV-related conditions. Those with HPV16 infection or anal dysplasia will be referred for high-resolution anoscopy (HRA) and may have biopsies taken for further analysis. Participants with anal dysplasia at entry may have follow-up HRA and optional study visits. Throughout the study, participants will provide blood and anal swab samples for immune and HPV assessments. Researchers will monitor immune responses by comparing pre- and post-vaccination samples and across participant groups based on HIV status and hormone exposure. The primary outcome is the immunogenicity of the HPV vaccine at seven months after the first dose. Safety and clinical management of anal dysplasia are also part of the study, which may continue through optional visits based on clinical findings.

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