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

NCT05266898 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-04-18

No results posted yet for this study

Summary

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

Interventions

BIOLOGICAL

Human papillomavirus 9-valent vaccine, recombinant

Subunit vaccine against 9 genotypes of human papillomavirus (6, 11, 16, 18, 31, 33, 45, 52, 58)

BIOLOGICAL

human papillomavirus vaccine, recombinant

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).

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Louisiana State University Health Sciences Center in New Orleans

    lead OTHER

Principal Investigators

  • Jennifer E Cameron, PhD · Louisiana State University Health Sciences Center

  • Michael E Hagensee, MD, PhD · Louisiana State University Health Sciences Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2025-12-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05266898 on ClinicalTrials.gov