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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00767897
First Posted: October 7, 2008
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Merck Sharp & Dohme Corp.
National Kidney Foundation
Information provided by (Responsible Party):
Corina Nailescu, Indiana University
  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: Observational Model: Other
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:


Further study details as provided by Corina Nailescu, Indiana University:

Enrollment: 72
Study Start Date: November 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767897


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

Responsible Party: Corina Nailescu, Associate Professor of Clinical Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT00767897     History of Changes
Other Study ID Numbers: 0807-02
First Submitted: October 6, 2008
First Posted: October 7, 2008
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by Corina Nailescu, Indiana University:
Dose response relationship
immunity

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Papilloma
Urologic Diseases
Renal Insufficiency
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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