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NCT00806676 · ClinicalTrials.gov registry record · NA
Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 67
- Enrollment target
NCT00806676: Completed NA study, sponsored by Johns Hopkins University.
NCT00806676 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 67 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00806676, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 67 participants
- Enrollment target
Study Summary
People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to immune response abnormalities, the CKD population may or may not respond to the recommended three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and 18-related genital tract disease. The objective of this study is to measure the antibody response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD) (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant. Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained at months 0, 7 and 24.
Interventions
- DRUG Gardasil® Vaccine (FDA-approved vaccination regimen)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2008-12 |
| Est. Completion | 2015-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00806676
The ClinicalTrials.gov registry entry for NCT00806676 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gardasil® Vaccine (FDA-approved vaccination regimen) is the first listed.
NCT00806676 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00806676 about?
NCT00806676 is a clinical study titled "Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease". People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to immune response abnormalities...
What is the current status of trial NCT00806676?
This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2008-12. Estimated completion is 2015-08.
What interventions are being tested in trial NCT00806676?
The interventions under investigation include: Gardasil® Vaccine (FDA-approved vaccination regimen) (DRUG).
Who is sponsoring clinical trial NCT00806676?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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