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

Study acronym: AGO-Gard
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 18, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Enrollment target: 150 to 250v4 Show 9 more changesShow less
    • Primary completion date: Jun 2024 to Dec 2025
    • Primary endpoints: 1 to 2
    • Study completion date: Mar 2025 to Jun 2026
    • Interventions: Human papillomavirus 9-valent vaccine, recombinant (Biological) to Human papillomavirus 9-valent vaccine, recombinant (Biological), human papillomavirus vaccine, recombinant (Biological)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 76 words
    • Publications: 13 to 1
    • Study arms: 1 to 2
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 15, 2022 to Nov 30, 2022
    • Site details revised
    v3
  3. Start date: Apr 2022 to Sep 15, 2022v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05266898
Lead Sponsor Louisiana State University Health Sciences Center in New Orleans
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Papillomavirus Vaccines, Human Immunodeficiency Virus, Papillomavirus Infection, Serology, Cervical Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia, Oral Cavity Infection
Related terms Acquired Immunodeficiency Syndrome, Papillomavirus Infections, Uterine Cervical Dysplasia
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov