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

Recruiting now · Phase 4

Conditions studied: Papillomavirus Vaccines, Human Immunodeficiency Virus, Papillomavirus Infection, Serology, Cervical Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia, Oral Cavity Infection

In brief

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.

Key facts

Study ID

NCT05266898

Run by

Louisiana State University Health Sciences Center in New Orleans

People needed

250

Starts

2022-11-30

Expected to finish

2026-06-01

Last updated by the study team

2025-04-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• HIV seropositive
• immune intact (CD4+ T cell count in peripheral blood >200 cells/ml)
• HIV controlled (peripheral blood HIV viral load <1,000 genome copies/mL)
• Stable on antiretroviral regimen for ≥3 months
• Gardasil-9 naive and age ≤45 OR
• documented receipt of 3 doses of Gardasil-4 or Gardasil-9 HPV vaccine

You may not qualify if…

• Medical contraindication for vaccination (vaccine-naive arm only)
• Women who are pregnant
• Acute illness
• Taking chronic steroids, >0.5mg/kg prednisone or equivalent
• Taking immune modulating medications
• Received blood transfusion/blood products within the past 6 months
• Recipients of other vaccine products within the past month
• Inability to provide informed written consent

Where it is running

• University Medical Center New Orleans — New Orleans, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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