Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease

NCT ID: NCT00806676

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2015-08-31

Brief Summary

People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to immune response abnormalities, the CKD population may or may not respond to the recommended three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and 18-related genital tract disease. The objective of this study is to measure the antibody response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD) (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant. Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained at months 0, 7 and 24.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1. Chronic Kidney Disease, NKF Stage 1-4

Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.

Group Type: OTHER

Gardasil® Vaccine (FDA-approved vaccination regimen)

Intervention Type: DRUG

Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.

2. ESRD (dialysis)

Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.

Group Type: OTHER

Gardasil® Vaccine (FDA-approved vaccination regimen)

Intervention Type: DRUG

Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.

3. Kidney Transplant Recipient

Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.

Group Type: OTHER

Gardasil® Vaccine (FDA-approved vaccination regimen)

Intervention Type: DRUG

Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.

Interventions

Gardasil® Vaccine (FDA-approved vaccination regimen)

Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Females, aged 9-21 years, in the following groups:

• CKD (defined as estimated glomerular filtration rate between 90 ml/min/1.73m2 and 15 ml/min/1.73m2, as calculated by the Schwartz formula)
• ESRD (eGFR < 15 ml/min/1.73m2, or receiving chronic dialysis [peritoneal or hemodialysis])
• Status-post kidney transplant

Exclusion Criteria

• Within first 3 months post kidney transplant
• Within 3 months of kidney rejection episode
• Hypersensitivity to active substances or excipients of Gardasil vaccine

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey J Fadrowski, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Emory Healthcare & Children's Healthcare of Atlanta Pediatric Nephrology Clinic

Atlanta, Georgia, United States

Johns Hopkins University Harriet Lane Kidney Center, Rubenstein Child Health Bldg

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00020699

Identifier Type: -

Identifier Source: org_study_id