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NCT05266898 · ClinicalTrials.gov registry record · Phase 4
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
A Phase 4 study of Human Immunodeficiency Virus and Cervical Intraepithelial Neoplasia, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT05266898: Recruiting Phase 4 study of Human Immunodeficiency Virus and Cervical Intraepithelial Neoplasia, sponsored by Louisiana State University Health Sciences Center in New Orleans.
NCT05266898 is a Phase 4 study of Human Immunodeficiency Virus and Cervical Intraepithelial Neoplasia that is actively recruiting participants, run by Louisiana State University Health Sciences Center in New Orleans. The registered enrollment target is 250 participants, above the 178-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (40% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05266898, a Phase 4 study of Human Immunodeficiency Virus and Cervical Intraepithelial Neoplasia, is actively recruiting participants, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
serum antibodies against human papillomavirus genotypes 6,11,16,18,31,33,45,52, and 58
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2022-11-30 |
| Est. Completion | 2026-06 |
| Phase | Phase 4 |
What NCT05266898 shows while recruiting
NCT05266898 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 178-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (40% higher).
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.
NCT05266898 reports a single indexed study location in Louisiana.
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.
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).
Who is sponsoring clinical trial NCT05266898?
This trial is sponsored by Louisiana State University Health Sciences Center in New Orleans, which has 45 total clinical trials registered on ClinicalTrials.gov.
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.
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Where NCT05266898's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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