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

This study is currently recruiting participants.
Verified April 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta
ClinicalTrials.gov Identifier:
NCT00940940
First received: July 15, 2009
Last updated: April 13, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Transplant
 Biological: Zostavax (Live attenuated herpes zoster vaccine)
Biological: Placebo vaccine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Live Attenuated Herpes Zoster Vaccine in Patients Undergoing Living Donor Kidney Transplantations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Live attenuated herpes zoster vaccine Biological: Zostavax (Live attenuated herpes zoster vaccine)
0.6 mL subcutaneous
Other Name: Zostavax
Placebo Comparator: Placebo Biological: Placebo vaccine
0.65 mL subcutaneous

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940940

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Deepali Kumar     780492-3885     deepali.kumar@ualberta.ca    
Contact: Leticia Ely, Msc     780-492-3885        
Principal Investigator: Deepali Kumar, MD            
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Deepali Kumar, MD University of Alberta
  More Information

No publications provided

Responsible Party: Deepali Kumar, Assistant Professor of Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT00940940     History of Changes
Other Study ID Numbers: DKUA-001
Study First Received: July 15, 2009
Last Updated: April 13, 2012
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on May 21, 2013