Overview

This trial is active, not recruiting.

Condition kidney transplant
Treatments zostavax (live attenuated herpes zoster vaccine), placebo vaccine
Phase phase 4
Sponsor University of Alberta
Start date October 2009
End date June 2016
Trial size 40 participants
Trial identifier NCT00940940, DKUA-001

Summary

Varicella zoster virus is part of the herpesvirus group and causes chickenpox in exposed individuals. The majority of the population is seropositive for this virus. Reactivation of varicella zoster virus occurs in up to 30% of the general population over 60 years old.

Solid organ transplant recipients receive lifelong immunosuppression drugs and are at great risk of reactivation of all herpesviruses including the varicella zoster virus regardless of age. The vaccine has been shown to be effective in preventing shingles in the general population. The investigators' purpose is to determine how well the vaccine works in patients on renal replacement therapy and post-transplant.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Experimental)
zostavax (live attenuated herpes zoster vaccine) Zostavax
0.6 mL subcutaneous
(Placebo Comparator)
placebo vaccine
0.65 mL subcutaneous

Primary Outcomes

Measure
Immunogenicity
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Age 18-65 years 2. Listed or will likely be listed for live donor kidney transplant within one month Exclusion Criteria: 1. Previous receipt of Zostavax

Additional Information

Official title Safety and Immunogenicity of Live Attenuated Herpes Zoster Vaccine in Patients Undergoing Living Donor Kidney Transplantations
Principal investigator Deepali Kumar, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Alberta.