Status:
RECRUITING
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
Lead Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Papillomavirus Vaccines
Human Immunodeficiency Virus
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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. T...
Detailed Description
BACKGROUND AND SIGNIFICANCE HPV is the etiological agent for most if not all cervical and anal cancer and for over 50% of head and neck squamous cell carcinomas. HPV infection, pre-cancerous and canc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05266898
Start Date
November 30 2022
End Date
June 1 2026
Last Update
April 18 2025
Active Locations (1)
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1
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112