Back to search results

Gardasil-9 HPV Vaccine in People Living With HIV

This study is looking at how well the Gardasil-9 vaccine works in adults living with HIV. Researchers want to see how strong an immune response (serological response) your body makes to the vaccine, which protects against Human Papillomavirus (HPV). HPV can cause certain cancers. The study will also look at how well the Gardasil vaccine protects against HPV infections over time in people who have already been vaccinated. You might be able to join if you are 18-65 years old, have well-controlled HIV (CD4+ T cell count over 200 and viral load under 1,000), and are either new to Gardasil-9 or have already received Gardasil-4 or Gardasil-9.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main part of the study measures your immune response at 18 months after vaccination. For those already vaccinated, it's a single measurement at a variable time after vaccination.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05266898

Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV

Recruiting
PHASE4Ages 18–65InterventionalPrevention
Louisiana State University Health Sciences Center in New Orleans
~250 participants
Updated 2025-04-18 on ClinicalTrials.gov
What's tested:Human papillomavirus 9-valent vaccine, recombinanthuman papillomavirus vaccine, recombinant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
change in serological response to Gardasil-9
Measured over 18 months
+1 more outcome measured

Conditions

Papillomavirus Vaccines
Human Immunodeficiency Virus
Papillomavirus Infection
Serology
Cervical Intraepithelial Neoplasia
Anal Intraepithelial Neoplasia
Oral Cavity Infection

Explore related trials

HIV InfectionHuman Papillomavirus Infection

Where it's being run

1 sites across 1 states
Louisiana1

Study leadership

  • 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

Who to contact

Vice Chancellor for Academic Affairs and Research
[email protected]
504-568-4804
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • change in serological response to Gardasil-918 months

    serum antibodies against human papillomavirus genotypes 6,11,16,18,31,33,45,52, and 58

  • serum antibody titers in vaccine-experienced cohortVariable time-since-vaccine completion. Single time-point evaluation.

    serum antibody titers against Gardasil-9 vaccine HPV genotypes in cohort of individuals with prior vaccine history, compared to time-since-vaccine completion