Overview

This trial is active, not recruiting.

Conditions chronic kidney disease, dialysis
Treatment human papillomavirus vaccine
Sponsor Indiana University
Collaborator Merck Sharp & Dohme Corp.
Start date November 2011
End date December 2016
Trial size 72 participants
Trial identifier NCT00767897, 0807-02

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
Girls and Boys age 9-18 with CKD stage 3 or 4
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.
Girls and Boys age 9-18 who are on dialysis
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.
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.
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.
Girls and Boys age 9-18
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 Criteria

Female participants from 9 years up to 18 years old.

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.

Additional Information

Official title The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients
Principal investigator Corina Nailescu, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Indiana University.