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

NCT00806676 | Completed Results

• 1 other identifier: NA_00020699
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

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

Keywords

chronic kidney disease; children; dialysis; kidney transplant; human papilloma virus; Gardasil; Chronic kidney disease (non-dialysis, dialysis, and kidney transplant) secondary to any cause.

Outcome Measures

Primary Outcomes (6)

• Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2

  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.

  Month 7

• Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2

  Month 7

• Percentage of Patients 9-15 Years of Age on Dialysis 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

Study Arms (3)

1. Chronic Kidney Disease, NKF Stage 1-4

OTHER

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.

Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)

2. ESRD (dialysis)

OTHER

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.

Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)

3. Kidney Transplant Recipient

OTHER

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.

Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)

Interventions

Gardasil® Vaccine (FDA-approved vaccination regimen) 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.

1. Chronic Kidney Disease, NKF Stage 1-4; 2. ESRD (dialysis); 3. Kidney Transplant Recipient

Eligibility Criteria

• Age: 9 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

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

Atlanta, Georgia, 30322, United States

Location

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

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

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

Results Point of Contact

• Title: Dr. Jeffrey Fadrowski
• Organization: Johns Hopkins University School of Medicine

jfadrow1@jhmi.edu

410-955-2467

Study Officials

• Jeffrey J Fadrowski, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 11, 2008
• Study Start: December 1, 2008
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 24, 2017
• Results First Posted: July 24, 2017

Record last verified: 2017-07

Locations

US (2)