drugset / Trial / NCT01137669

ZOSTAVAX® in Renal Transplant Patients

NCT01137669

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to test the safety of a licensed zoster vaccine, ZOSTAVAX® (Zoster Vaccine Live) in 40 subjects, age 18 years or older, with chronic kidney disease (CKD) who are scheduled to receive a living donor kidney transplant. ZOSTAVAX® is not licensed for use in immunosuppressed persons and in the United States for individuals less than 50 years of age. Subjects will receive either ZOSTAVAX® vaccine or placebo (inactive substance) no less than 4 weeks prior to their kidney transplant. Study procedures include: physical exam, blood samples and documentation of daily temperatures and/or side effects in a diary following vaccination. Participants may be involved in study related procedures for up to 18 months.

Timeline

Start
2010-09
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Varivax Vaccine 0.65 ml Subcutaneous

Indications