RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in People Living With Adequately Managed HIV

Quick Facts

Study Start:2022-11-30
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05266898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * HIV seropositive
  2. * immune intact (CD4+ T cell count in peripheral blood \>200 cells/ml)
  3. * HIV controlled (peripheral blood HIV viral load \<1,000 genome copies/mL)
  4. * Stable on antiretroviral regimen for ≥3 months
  5. * Gardasil-9 naive and age ≤45 OR
  6. * documented receipt of 3 doses of Gardasil-4 or Gardasil-9 HPV vaccine
  1. * Medical contraindication for vaccination (vaccine-naive arm only)
  2. * Women who are pregnant
  3. * Acute illness
  4. * Taking chronic steroids, \>0.5mg/kg prednisone or equivalent
  5. * Taking immune modulating medications
  6. * Received blood transfusion/blood products within the past 6 months
  7. * Recipients of other vaccine products within the past month
  8. * Inability to provide informed written consent

Contacts and Locations

Study Contact

Vice Chancellor for Academic Affairs and Research
CONTACT
504-568-4804
dporch@lsuhsc.edu
Executive Director, Office of Research Services
CONTACT
504-568-4985
jalam@lsuhsc.edu

Principal Investigator

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

Study Locations (Sites)

University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States

Collaborators and Investigators

Sponsor: Louisiana State University Health Sciences Center in New Orleans

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-30
Study Completion Date2026-06

Study Record Updates

Study Start Date2022-11-30
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Gardasil-9 HPV vaccine
  • human papillomavirus
  • human immunodeficiency virus

Additional Relevant MeSH Terms

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