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Clinical trialNCT05266898RecruitingPhase 4Interventional

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

SponsorLouisiana State University Health Sciences Center in New OrleansEnrollment250Anal Intraepithelial NeoplasiaCervical Intraepithelial NeoplasiaHuman Immunodeficiency VirusOral Cavity InfectionPapillomavirus InfectionPapillomavirus Vaccines+1 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Jennifer E Cameron, PhD

    Louisiana State University Health Sciences Center

    Principal Investigator
  • Michael E Hagensee, MD, PhD

    Louisiana State University Health Sciences Center

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University Medical Center New Orleans

    New Orleans, Louisiana, United States

    Jennifer E Cameron, PhDMichael E Hagensee, MD PhD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PAPILLOMAVIRUS HUMAN 9-VALENT VACCINEHuman papillomavirus vaccine, recombinant
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2022
Primary completion
31 Dec 2025
Completion
30 Jun 2026
Last update posted
18 Apr 2025
Registered enrollment
250
Registry id
NCT05266898

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.