Evaluating the Gardasil-9 HPV vaccine in adults with HIV
Official title: Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in People Living With Adequately Managed HIV
Run by Louisiana State University Health Sciences Center in New Orleans · NCT05266898 · Data updated 2026-11-12
This study is testing how well the Gardasil-9 HPV vaccine works for adults with well-controlled HIV to see if their immune response is similar to those without HIV.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Louisiana State University Health Sciences Center in New Orleans Academic / other |
| Drugs / interventions | prednisone, cART |
| Locations | 1 site (New Orleans, Louisiana) |
| Status | Recruiting |
| Started | November 30, 2022 |
| Main results expected | December 2025 |
| Study ends | June 2026 |
| Registry record updated | April 18, 2025 |
| Trial ID | NCT05266898 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include HIV-positive adults with a CD4+ T cell count above 200 cells/ml and a controlled viral load.
✕Probably not a fit
Patients who are pregnant, have acute illnesses, or are on immune-modulating medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the immune response to the Gardasil-9 HPV vaccine in adults living with well-controlled HIV. It will measure the serum antibody response and observe short-term clinical outcomes related to HPV infections after vaccination. The study hypothesizes that individuals with controlled HIV will have a comparable immune response to the vaccine as those without HIV. Additionally, it will evaluate the long-term protection offered by the vaccine against HPV-related diseases.
Why it matters
Potential benefit: If successful, this study could enhance HPV vaccination strategies for adults living with HIV, potentially reducing their risk of HPV-related cancers.
How similar studies have gone: Previous studies have shown promising results with HPV vaccination in HIV populations, but this specific approach with Gardasil-9 is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University Medical Center New Orleans
New Orleans, Louisiana, United States Recruiting
Study contacts
- Principal investigator: Jennifer E Cameron, PhD — Louisiana State University Health Sciences Center
- Study coordinator: Vice Chancellor for Academic Affairs and Research
- Email: dporch@lsuhsc.edu
- Phone: 504-568-4804
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.