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RECRUITING Phase 4

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

NCT05266898 · View on ClinicalTrials.gov ↗

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.

Interventions

  • BIOLOGICAL Human papillomavirus 9-valent vaccine, recombinant
  • BIOLOGICAL human papillomavirus vaccine, recombinant

Study Locations (1)

Louisiana

  • University Medical Center New Orleans — New Orleans

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2022-11-30
Est. Completion 2026-06
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05266898

The ClinicalTrials.gov registry entry for NCT05266898 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Louisiana State University Health Sciences Center in New Orleans, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 2 interventions — of which Human papillomavirus 9-valent vaccine, recombinant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05266898 reports 1 study location spanning 1 distinct geographic area — top geographies include Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05266898 about?

NCT05266898 is a clinical study titled "Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV". 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 ge...

What is the current status of trial NCT05266898?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 250 participants. The study started on 2022-11-30. Estimated completion is 2026-06.

What conditions does trial NCT05266898 study?

This clinical trial studies the following conditions: Human Immunodeficiency Virus, Cervical Intraepithelial Neoplasia, Papillomavirus Vaccines, Papillomavirus Infection, Serology. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05266898?

The interventions under investigation include: Human papillomavirus 9-valent vaccine, recombinant (BIOLOGICAL), human papillomavirus vaccine, recombinant (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05266898?

This trial is sponsored by Louisiana State University Health Sciences Center in New Orleans, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05266898 being conducted?

This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial