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

Indiana University

Status: Completed

Conditions: Chronic Kidney Disease; Dialysis

Treatments: Drug: Human Papillomavirus Vaccine

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00767897

0807-02

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 9 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

72 participants in 4 patient groups

CKD stage 3 or 4

Description:

Girls and Boys age 9-18 with CKD stage 3 or 4

Treatment:

Drug: Human Papillomavirus Vaccine

On dialysis

Description:

Girls and Boys age 9-18 who are on dialysis

Treatment:

Drug: Human Papillomavirus Vaccine

Transplanted

Description:

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.

Treatment:

Drug: Human Papillomavirus Vaccine

Healthy

Description:

Girls and Boys age 9-18

Treatment:

Drug: Human Papillomavirus Vaccine