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OpenTrials
Completed

NCT Number: NCT00806676

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

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.

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Key information

Conditions

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

Age range

9 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emory Healthcare & Children's Healthcare of Atlanta Pediatric Nephrology Clinic, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: Month 7

  3. Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2

    Time frame: Month 7

  4. Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2

    Time frame: Month 7

  5. Percentage of Patients 9-15 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2

    Time frame: Month 7

  6. Percentage of Patients 16-21 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2

    Time frame: Month 7

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2008
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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