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

NCT00806676 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2017-07-24

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey J Fadrowski, MD, MHS · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00806676 on ClinicalTrials.gov