NCT05266898 Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
| NCT ID | NCT05266898 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Louisiana State University Health Sciences Center in New Orleans |
| Condition | Papillomavirus Vaccines |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-11-30 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 250 participants in total. It began in 2022-11-30 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
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
Contact & Investigator
Jennifer E Cameron, PhD
PRINCIPAL INVESTIGATOR
Louisiana State University Health Sciences Center
Frequently Asked Questions
Who can join the NCT05266898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Papillomavirus Vaccines. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05266898 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05266898 currently recruiting?
Yes, NCT05266898 is actively recruiting participants. Contact the research team at dporch@lsuhsc.edu for enrollment information.
Where is the NCT05266898 trial being conducted?
This trial is being conducted at New Orleans, United States.
Who is sponsoring the NCT05266898 clinical trial?
NCT05266898 is sponsored by Louisiana State University Health Sciences Center in New Orleans. The principal investigator is Jennifer E Cameron, PhD at Louisiana State University Health Sciences Center. The trial plans to enroll 250 participants.