Antibody Response to Human Papillomavirus Recombinant Vaccine (Gardasil®) in Girls and Young Women With Chronic Kidney Disease
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 9 - 21 |
| Updated: | 4/21/2016 |
| Start Date: | December 2008 |
| End Date: | August 2015 |
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.
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.
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
We found this trial at
2
sites
Atlanta, Georgia 30322
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Baltimore, Maryland 21287
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