Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
Information source: Johns Hopkins University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease
Intervention: Gardasil® Vaccine (FDA-approved vaccination regimen) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s):
Jeffrey J Fadrowski, MD, MHS, Principal Investigator, Affiliation: Johns Hopkins University
Overall contact:
Jeffrey J Fadrowski, MD, MHS, Phone: 410-955-2467, Email: jfadrow1@jhmi.edu
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.
Clinical Details
Official title: Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Geometric mean antibody titers to HPV 6, 11, 16 and 18.
Eligibility
Minimum age: 9 Years.
Maximum age: 21 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Jeffrey J Fadrowski, MD, MHS, Phone: 410-955-2467, Email: jfadrow1@jhmi.edu
Emory Healthcare & Children's Healthcare of Atlanta Pediatric Nephrology Clinic, Atlanta, Georgia 30322, United States; Recruiting
Sandra G Amaral, MD, MHS, Phone: 404-727-8213, Email: sandra_amaral@oz.ped.emory.edu
Sandra G Amaral, MD, MHS, Principal Investigator
Johns Hopkins University Harriet Lane Kidney Center, Rubenstein Child Health Bldg, Baltimore, Maryland 21287, United States; Recruiting
Jeffrey J Fadrowski, MD, MHS, Phone: 410-955-2467, Email: jfadrow1@jhmi.edu
Katie Alcorn, BA, Phone: 443-287-5393, Email: kalcorn1@jhmi.edu
Jeffrey J Fadrowski, MD, MHS, Principal Investigator
Additional Information
Starting date: December 2008
Last updated: May 25, 2010
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