Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
Chronic Kidney Disease
About this trial
This is an interventional other trial for Chronic Kidney Disease focused on measuring chronic kidney disease, children, dialysis, kidney transplant, human papilloma virus, Gardasil, Chronic kidney disease (non-dialysis, dialysis, and kidney transplant) secondary to any cause.
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
Sites / Locations
- Emory Healthcare & Children's Healthcare of Atlanta Pediatric Nephrology Clinic
- Johns Hopkins University Harriet Lane Kidney Center, Rubenstein Child Health Bldg
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
1. Chronic Kidney Disease, NKF Stage 1-4
2. ESRD (dialysis)
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 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.
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.
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.