Actively Recruiting
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
Led by Louisiana State University Health Sciences Center in New Orleans · Updated on 2025-04-18
250
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
L
Louisiana State University Health Sciences Center in New Orleans
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV seropositive
- CD4+ T cell count in peripheral blood greater than 200 cells/ml
- HIV viral load less than 1,000 genome copies/mL
- Stable on antiretroviral regimen for at least 3 months
- Either Gardasil-9 vaccine naive and age 45 or younger, or documented receipt of 3 doses of Gardasil-4 or Gardasil-9 HPV vaccine
You will not qualify if you...
- Medical contraindication for vaccination (for vaccine-naive participants only)
- Pregnant women
- Acute illness
- Taking chronic steroids greater than 0.5mg/kg prednisone or equivalent
- Taking immune modulating medications
- Received blood transfusion or blood products within the past 6 months
- Received other vaccine products within the past month
- Unable to provide informed written consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
Research Team
V
Vice Chancellor for Academic Affairs and Research
CONTACT
E
Executive Director, Office of Research Services
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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