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

March 28, 2024 updated by: Corina Nailescu, Indiana University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University/Riley Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Merck Sharp & Dohme LLC
National Kidney Foundation

Investigators

  • Principal Investigator: Corina Nailescu, M.D., Indiana University/Riley Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 6, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimated)

October 7, 2008

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0807-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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