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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00806676
First received: December 9, 2008
Last updated: May 25, 2010
Last verified: May 2010

December 9, 2008
May 25, 2010
December 2008
June 2011   (final data collection date for primary outcome measure)
Geometric mean antibody titers to HPV 6, 11, 16 and 18. [ Time Frame: Baseline, Months 7 and 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00806676 on ClinicalTrials.gov Archive Site
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Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
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.

Not Provided
Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Chronic Kidney Disease
Drug: 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.
  • 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.
    Intervention: Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)
  • 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.
    Intervention: Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)
  • 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.
    Intervention: Drug: Gardasil® Vaccine (FDA-approved vaccination regimen)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
June 2011   (final data collection date for primary outcome measure)

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
Female
9 Years to 21 Years
No
Contact: Jeffrey J Fadrowski, MD, MHS 410-955-2467 jfadrow1@jhmi.edu
United States
 
NCT00806676
MERCK_33610
No
Jeffrey Fadrowski MD, MHS/Assistant Professor of Pediatrics, Johns Hopkins University School of Medicine
Johns Hopkins University
Merck Sharp & Dohme Corp.
Principal Investigator: Jeffrey J Fadrowski, MD, MHS Johns Hopkins University
Johns Hopkins University
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP