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NCT00940940 Clinical Trial

Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation

Kidney Transplant Clinical Trial

Official title:
Safety and Immunogenicity of Live Attenuated Herpes Zoster Vaccine in Patients Undergoing Living Donor Kidney Transplantations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00940940
Other study ID # DKUA-001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2009
Est. completion date September 23, 2013

Study information
Verified date May 2015
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date September 23, 2013
Est. primary completion date August 26, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Zostavax (Live attenuated herpes zoster vaccine)
0.6 mL subcutaneous
• Placebo vaccine
0.65 mL subcutaneous

Locations
Country Name City State
Canada University of Alberta Hospital Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immunogenicity 6 months
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