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

RecruitingPhase 4Ages 18 Years - 65 YearsAllLouisiana State University Health Sciences Center…
NCT05266898 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Human papillomavirus 9-valent vaccine, recombinant
  • human papillomavirus vaccine, recombinant
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Where

1 site
University Medical Center New Orleans
New Orleans, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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