Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV

The primary objective of this study is to determine the magnitude and breadth of the serum antibody response to the nonavalent HPV vaccine (Gardasil-9) in adults with well-controlled HIV infection. The secondary objectives of the study are to observe short term clinical outcomes of prevalent HPV genotype-specific anogenital infections in adults living with HIV who complete the three-dose Gardasil-9 vaccine series, and to determine the protection afforded by Gardasil vaccine over time in previously vaccinated adults living with HIV. The clinical hypothesis is that adults with virologically controlled HIV mount a serum antibody response to the nonavalent HPV vaccine that is comparable to HIV negative counterparts. We also postulate that HPV vaccination will provide short-term clinical benefit against HPV infections and disease associated with vaccine genotypes and continuing protection against vaccine genotypes of HPV over time.

NCT Number	NCT05266898
Lead Sponsor	Louisiana State University Health Sciences Center in New Orleans Collaborators: Merck Sharp & Dohme LLC
Conditions	Papillomavirus Vaccines, Human Immunodeficiency Virus, Papillomavirus Infection, Serology, Cervical Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia, Oral Cavity Infection
Enrollment	250 participants
Start Date	2022-11-30
Primary Completion	2025-12 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2025-04-18