Clinical trial NCT00806676: Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
Official title: Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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.
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-12-11
Enrollment: 67
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2
timeFrame: Month 7
measure: Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2
timeFrame: Month 7
measure: Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2
timeFrame: Month 7
measure: Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2
timeFrame: Month 7
measure: Percentage of Patients 9-15 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2
timeFrame: Month 7
measure: Percentage of Patients 16-21 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2
timeFrame: Month 7
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Healthcare & Children's Healthcare of Atlanta Pediatric Nephrology Clinic
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University Harriet Lane Kidney Center, Rubenstein Child Health Bldg
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jeffrey J Fadrowski, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: