Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in Adults Living With Well-Controlled HIV

What this Trial Is About

Researchers are investigating the immune response to the nonavalent HPV vaccine (Gardasil-9) in adults living with well-controlled HIV infection. The study aims to measure how strongly and broadly the serum antibody response develops after vaccination. It also seeks to observe short-term clinical effects on HPV infections and related diseases, and to evaluate the protection Gardasil-9 provides over time in those previously vaccinated. The study focuses on adults with virologically controlled HIV and compares their immune response with HIV-negative individuals. Participants will receive the Gardasil-9 vaccine in a three-dose series given at 0, 1, and 6 months. There is also a second group of adults who have already completed a full Gardasil vaccine series prior to joining. Both groups will be monitored with blood, saliva, and swab samples collected at various visits to assess antibody levels and HPV infection status. The study includes men and women representative of a diverse population and involves detailed laboratory testing of samples to identify HPV types and antibody responses. Throughout the 18-month study period, participants will complete surveys and provide biological samples at scheduled visits to track immune response and clinical outcomes related to HPV infection and disease. Researchers will analyze antibody titers, HPV infection clearance or persistence, and tissue changes associated with HPV. Data will be evaluated over time and compared to historical HIV-negative controls. Safety monitoring includes observation after vaccination and collection of relevant clinical laboratory data. The total participation duration extends up to 18 months with multiple follow-up assessments.

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