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.
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 67
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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. arm 3: 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.

Interventions: intervention 1: Gardasil® Vaccine (FDA-approved vaccination regimen)
Intervention descriptions: intervention 1: 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.

Protocol document: