OncoMatch/Clinical Trials/NCT05266898
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
Is NCT05266898 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Human papillomavirus 9-valent vaccine, recombinant and human papillomavirus vaccine, recombinant for papillomavirus vaccines.
Treatment: Human papillomavirus 9-valent vaccine, recombinant · human papillomavirus vaccine, recombinant — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CD4 count >200 cells/ml (>200 cells/ml)
immune intact (CD4+ T cell count in peripheral blood >200 cells/ml)
Required: HIV viral load <1,000 genome copies/mL (<1,000 genome copies/mL)
HIV controlled (peripheral blood HIV viral load <1,000 genome copies/mL)
Prior therapy
Must have received: antiretroviral therapy
Stable on antiretroviral regimen for ≥3 months
Cannot have received: blood transfusion or blood products
Received blood transfusion/blood products within the past 6 months
Cannot have received: other vaccine products
Recipients of other vaccine products within the past month
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University Medical Center New Orleans · New Orleans, Louisiana
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