The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients

Indiana University72 enrolled

Overview

The proposed study is a pilot study and a first step towards developing an optimized HPV vaccination strategy for girls who have CKD, or are on dialysis or have a kidney transplant.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Kidney Disease Dialysis

Interventions

Human Papillomavirus VaccineDRUG

The HPV vaccination will be administered by intramuscular injection in three separate 0.5mL doses. The recommended schedule is a 3-dose series with dose #2 and #3 administered 2 and 6 months after dose #1, respectively. The minimum interval between dose #1 and #2 of the vaccine is 4 weeks. The minimum recommended interval between dose #2 and #3 of the vaccine is 12 weeks.

Eligibility

Sex: FEMALEMin age: 9 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 9-18-year-old girls who have CKD stages 3 or 4 (Glomerular filtration rates 15-59 mL/min/1.73m2). * 9-18-year-old girls who are on dialysis. * 9-18-year-old girls who have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen. * Healthy 9-18-year-old girls Exclusion Criteria: * Pregnancy, fever, allergy to any vaccine component, any immune disorder and any blood product received in the previous 6 months.

Locations (1)

Indiana University/Riley Children's Hospital

Indianapolis, Indiana, United States

Data from ClinicalTrials.gov

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