NCT05266898RecruitingPhase 4
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in People Living With Adequately Managed HIV
Source: ClinicalTrials.gov · Last updated 18 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 23 Feb 2022
- Start date
- 30 Nov 2022
- Primary completion date
- Dec 2025
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Diseases
- HIV
- NCT number
- NCT05266898
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 250
- From 30 Nov 2022 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medical contraindication for vaccination (vaccine-naive arm only)
- 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
Other illness
- Acute illness
Other
- Women who are pregnant
- Inability to provide informed written consent
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.