Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
Launched by LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER IN NEW ORLEANS · Mar 3, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well the Gardasil-9 HPV vaccine works for adults living with HIV who have their virus under control. The main goal is to see how the vaccine triggers the body to produce antibodies, which are proteins that help fight infections. Researchers believe that adults with well-managed HIV will respond to the vaccine similarly to those without HIV. Additionally, the study will look at whether getting vaccinated can help reduce specific HPV infections in these individuals.
To participate in this trial, you need to be HIV positive but in good health, meaning your immune system is functioning well and your virus levels are low. You should also have been on a stable HIV treatment for at least three months and have never received the Gardasil-9 vaccine before. Participants will receive three doses of the vaccine and will be monitored for their body’s response and any short-term benefits against HPV-related conditions. This study is currently recruiting participants, and it's open to anyone aged 16 and older.
Gender
ALL
Eligibility criteria
- 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
About Louisiana State University Health Sciences Center In New Orleans
Louisiana State University Health Sciences Center in New Orleans (LSUHSC-NO) is a premier academic institution dedicated to advancing health through innovative research, education, and patient care. As a leading sponsor of clinical trials, LSUHSC-NO leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous scientific investigations aimed at improving health outcomes. The center is committed to fostering collaboration among researchers, clinicians, and community partners, ensuring the translation of research findings into effective therapeutic interventions. With a focus on diverse health challenges, LSUHSC-NO is at the forefront of medical research in the region, striving to enhance healthcare quality and accessibility for all populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Orleans, Louisiana, United States
Patients applied
Trial Officials
Jennifer E Cameron, PhD
Principal Investigator
Louisiana State University Health Sciences Center
Michael E Hagensee, MD, PhD
Principal Investigator
Louisiana State University Health Sciences Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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