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Clinical Trial Details

Trial ID: L0210
Source ID: NCT00806676
Associated Drug: Gardasil® Vaccine (Fda-Approved Vaccination Regimen)
Title: Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00806676/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: Gardasil® Vaccine (FDA-approved vaccination regimen)
Outcome Measures: Primary: Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2, The primary outcome was antibody response to each of four HPV genotypes contained within the HPV vaccine at the time periods specified for the blood draws. Antibody levels, measured by Merck GmbH, were initially determined using the competitive Luminex immunoassay(cLIA; Merck GmbH), the assay used in the original licensing studies. Seropositivity was defined as being above thresholds set at 20, 16, 20, and 24 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively, as determined in phase 2 studies among patients who were immunocompetent. Antibody levels were reanalyzed using the newer, more sensitive IgG cLIA in stored serum from blood draws 2 and 3. Seropositivity for this assay was defined as being above thresholds set at 15, 15, 7, and 10 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively., Month 7|Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2, Month 7|Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2, Month 7|Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2, Month 7|Percentage of Patients 9-15 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2, Month 7|Percentage of Patients 16-21 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2, Month 7 |
Sponsor/Collaborators: Sponsor: Johns Hopkins University | Collaborators: Merck Sharp & Dohme LLC
Gender: FEMALE
Age: CHILD, ADULT
Phases:
Enrollment: 67
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2008-12
Completion Date: 2015-08
Results First Posted: 2017-07-24
Last Update Posted: 2017-07-24
Locations: Emory Healthcare & Children's Healthcare of Atlanta Pediatric Nephrology Clinic, Atlanta, Georgia, 30322, United States|Johns Hopkins University Harriet Lane Kidney Center, Rubenstein Child Health Bldg, Baltimore, Maryland, 21287, United States
URL: https://clinicaltrials.gov/show/NCT00806676

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress