Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease

Completed · Not applicable

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT00806676

Run by

Johns Hopkins University

People needed

67

Starts

2008-12-01

Expected to finish

2015-08-01

Last updated by the study team

2017-07-24

Who can join

Age: 9 and older, up to 21. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Within first 3 months post kidney transplant
• Within 3 months of kidney rejection episode
• Hypersensitivity to active substances or excipients of Gardasil vaccine

Where it is running

• Emory Healthcare & Children's Healthcare of Atlanta Pediatric Nephrology Clinic — Atlanta, Georgia, United States
• Johns Hopkins University Harriet Lane Kidney Center, Rubenstein Child Health Bldg — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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