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

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Papillomavirus Vaccines
Intervention / Treatment

-

Contacts and Locations

New Orleans

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

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

2026-06