Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV (NCT05266898) | Clinical Trial Compass
RecruitingPhase 4
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
United States250 participantsStarted 2022-11-30
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in serological response to Gardasil-9
Timeframe: 18 months
2
serum antibody titers in vaccine-experienced cohort
Timeframe: Variable time-since-vaccine completion. Single time-point evaluation.
Trial details
NCT IDNCT05266898
SponsorLouisiana State University Health Sciences Center in New Orleans