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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Deepali Kumar, University of Alberta.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta Identifier:
First received: July 15, 2009
Last updated: May 26, 2015
Last verified: May 2015

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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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:

Further study details as provided by Deepali Kumar, University of Alberta:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: 6 months ]

Estimated Enrollment: 40
Study Start Date: October 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00940940

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Principal Investigator: Deepali Kumar, MD University of Alberta
  More Information

Responsible Party: Deepali Kumar, Assistant Professor of Medicine, University of Alberta Identifier: NCT00940940     History of Changes
Other Study ID Numbers: DKUA-001
Study First Received: July 15, 2009
Last Updated: May 26, 2015

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs processed this record on September 19, 2017