drugset / Trial / NCT06624839
Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
Non-randomizedParallel-groupOpen-labelPrevention
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).
Timeline
- Start
- 2025-03-15
- Primary completion
- 2027-01
- Completion
- 2028-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gardasil 9 | Vaccine | 0.5 ml | Intramuscular |