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

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Louisiana State University Health Sciences Center in New Orleans
Study ID
NCT05266898
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Human papillomavirus 9-valent vaccine, recombinant — BIOLOGICAL
    Subunit vaccine against 9 genotypes of human papillomavirus (6, 11, 16, 18, 31, 33, 45, 52, 58)
  • human papillomavirus vaccine, recombinant — BIOLOGICAL
    Subunit vaccine against four (6, 11, 16, 18) or nine (6, 11, 16, 18, 31, 33, 45, 52, 58) genotypes of human papillomavirus. Administered as part of participant's clinical care prior to study enrollment (intervention not delivered as part of study design).

Study Details

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.

Key Dates

Start date
Nov 30, 2022
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Gardasil-9 recipients
    Participants receive 3-dose Gardasil-9 vaccine series.
  • Other: Gardasil vaccine experienced cohort
    Observational cohort to determine Gardasil HPV serum antibody titers in relation to time since vaccine series completion.

Primary Outcome Measure

change in serological response to Gardasil-9 [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Medical Center New OrleansNew OrleansLouisiana70112
Jyotsna Fuloria
[email protected]
504-702-4900
Jennifer E Cameron, PhD (PRINCIPAL_INVESTIGATOR)
Michael E Hagensee, MD PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Orleans, LA

By condition
HIV
By specialty
Infectious disease
By research site
University Medical Center New Orleans· New Orleans, LA

Related Studies