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

Sponsors and Collaborators:	Indiana University Merck National Kidney Foundation
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00767897

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

U.S. FDA Resources

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

Further study details as provided by Indiana University:

Estimated Enrollment:	120
Study Start Date:	April 2009

Groups/Cohorts	Assigned Interventions
CKD stage 3 or 4 Sexually naive girls age 9-14 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 Sexually naive girls age 9-14 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 Sexually naive girls age 9-14 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 Sexually naive girls age 9-14	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 14 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Sexually naive girls age 9-14 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:

9-14-year-old girls who are sexually-naÃ-ve (based on a questionnaire and an assessment by the investigator) and have CKD stages 3 or 4 (Glomerular filtration rates 15-59 mL/min/1.73m2).
9-14-year-old girls who are sexually-naÃ-ve (based on a questionnaire and an assessment by the investigator) and are on dialysis.
9-14-year-old girls who are sexually-naive (based on a questionnaire and an assessment by the investigator), have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen.
Healthy 9-14-year-old girls who are sexually-naÃ-ve (based on a questionnaire and an assessment by the investigator).

Exclusion Criteria:

Pregnancy (determined by serum Î²-HCG testing), 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
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Merck

National Kidney Foundation

Investigators

Principal Investigator:

Corina Nailescu, M.D.

Indiana University/Riley Children's Hospital

More Information

Responsible Party:	Indiana Universtiy Hospital/Riley Children's Hospital ( Dr. Corina Nailescu )
Study ID Numbers:	0807-02
Study First Received:	October 6, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00767897
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

Dose response relationship
immunity

Study placed in the following topic categories:

Virus Diseases
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Papilloma
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009