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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease Dialysis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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CKD stage 3 or 4

Girls and Boys age 9-18 with CKD stage 3 or 4

Human Papillomavirus Vaccine

Intervention Type DRUG

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.

On dialysis

Girls and Boys age 9-18 who are on dialysis

Human Papillomavirus Vaccine

Intervention Type DRUG

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.

Transplanted

Girls and Boys age 9-18 who have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen.

Human Papillomavirus Vaccine

Intervention Type DRUG

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.

Healthy

Girls and Boys age 9-18

Human Papillomavirus Vaccine

Intervention Type DRUG

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.

Interventions

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Human Papillomavirus Vaccine

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.

Intervention Type DRUG

Eligibility Criteria

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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