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

This study is currently recruiting participants.
Verified April 2013 by Indiana University
Sponsor:
Collaborators:
Merck
National Kidney Foundation
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00767897
First received: October 6, 2008
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Dialysis
 Drug: Human Papillomavirus Vaccine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Indiana University:

Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CKD stage 3 or 4
Girls and Boys age 9-18 with CKD stage 3 or 4
 Drug: 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.
On dialysis
Girls and Boys age 9-18 who are on dialysis
 Drug: 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.
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.
 Drug: 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.
Healthy
Girls and Boys age 9-18
 Drug: 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.

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Girls age 9-18 who are healthy, have chronic kidney disease stage 3 or 4, are on dialysis, or have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767897

Contacts
Contact: Corina Nailescu, M.D. 317-274-2563 cnailesc@iupui.edu

Locations
United States, Indiana
Indiana University/Riley Children's Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Corina Nailescu, M.D.            
Sponsors and Collaborators
Indiana University
Merck
National Kidney Foundation
Investigators
Principal Investigator: Corina Nailescu, M.D. Indiana University/Riley Children's Hospital
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00767897     History of Changes
Other Study ID Numbers: 0807-02
Study First Received: October 6, 2008
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Dose response relationship
immunity

Additional relevant MeSH terms:
Kidney Diseases
Papilloma
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
 Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013