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

NCT00767897 | Completed DMC

• 1 other identifier: 0807-02
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; Dialysis

Keywords

Dose response relationship; immunity

Study Arms (4)

CKD stage 3 or 4

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

Drug: Human Papillomavirus Vaccine

On dialysis

Girls and Boys age 9-18 who are on dialysis

Drug: Human Papillomavirus Vaccine

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

Healthy

Girls and Boys age 9-18

Drug: Human Papillomavirus Vaccine

Interventions

Human Papillomavirus Vaccine DRUG

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.

CKD stage 3 or 4; Healthy; On dialysis; Transplanted

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• year-old girls who have CKD stages 3 or 4 (Glomerular filtration rates 15-59 mL/min/1.73m2).
• year-old girls who are on dialysis.
• 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

You may not qualify if:

• Pregnancy, fever, allergy to any vaccine component, any immune disorder and any blood product received in the previous 6 months.

Sponsors & Collaborators

• Indiana University: lead
• Merck Sharp & Dohme LLC: collaborator
• National Kidney Foundation, United States: collaborator

Study Sites (1)

Indiana University/Riley Children's Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Corina Nailescu, M.D.

  Indiana University/Riley Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 7, 2008
• Study Start: November 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

US (1)