View Clinical Trial (Medical Research Study)
Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
| City: |
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Atlanta |
| State: |
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Georgia |
| Zip Code: |
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30322 |
| Conditions: |
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Chronic Kidney Disease |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
Females, aged 9-21 years, in the following groups:
- CKD (defined as estimated glomerular filtration rate between 90 ml/min/1.73m2 and 15
ml/min/1.73m2, as calculated by the Schwartz formula)
- ESRD (eGFR < 15 ml/min/1.73m2, or receiving chronic dialysis [peritoneal or
hemodialysis])
- Status-post kidney transplant
Exclusion Criteria:
- Within first 3 months post kidney transplant
- Within 3 months of kidney rejection episode
- Hypersensitivity to active substances or excipients of Gardasil vaccine
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| NCT ID: |
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NCT00806676 |
| Primary Contact: |
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Principal Investigator
Jeffrey J Fadrowski, MD, MHS
Johns Hopkins University
Jeffrey J Fadrowski, MD, MHS
Phone: 410-955-2467
Email: jfadrow1@jhmi.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Atlanta, Georgia 30322
United States
Sandra G Amaral, MD, MHS
Phone: 404-727-8213
Email: sandra_amaral@oz.ped.emory.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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