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

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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Key information

Conditions

Chronic Kidney Disease Chronic Disease Dialysis Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

9 year–18 year

Sex eligibility

Female

Study type

Observational

Primary location

Indiana University/Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Human Papillomavirus Vaccine

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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

Merck Sharp & Dohme LLC
National Kidney Foundation, United States

Registry information

Important dates

Study start: 2011
Primary completion: 2018
Study completion: 2018
First posted: Oct 7, 2008
Registry last updated: Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed