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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)

• Registration Number: NCT00806676
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-11
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2017-04-18
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-20
• Last Update Submitted: 2017-07-20
• Results First Posted: 2017-07-24
• Last Update Posted: 2017-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2. ESRD (dialysis)	Gardasil® Vaccine (FDA-approved vaccination regimen)	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.
1. Chronic Kidney Disease, NKF Stage 1-4	Gardasil® Vaccine (FDA-approved vaccination regimen)	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.
3. Kidney Transplant Recipient	Gardasil® Vaccine (FDA-approved vaccination regimen)	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2	Month 7
Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2	Month 7	The primary outcome was antibody response to each of four HPV genotypes contained within the HPV vaccine at the time periods specified for the blood draws. Antibody levels, measured by Merck GmbH, were initially determined using the competitive Luminex immunoassay(cLIA; Merck GmbH), the assay used in the original licensing studies. Seropositivity was defined as being above thresholds set at 20, 16, 20, and 24 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively, as determined in phase 2 studies among patients who were immunocompetent. Antibody levels were reanalyzed using the newer, more sensitive IgG cLIA in stored serum from blood draws 2 and 3. Seropositivity for this assay was defined as being above thresholds set at 15, 15, 7, and 10 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively.
Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2	Month 7
Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2	Month 7
Percentage of Patients 9-15 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2	Month 7
Percentage of Patients 16-21 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2	Month 7

Trial Locations

Locations (2)

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