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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00940940
Recruitment Status : Unknown
Verified May 2015 by Deepali Kumar, University of Alberta.
Recruitment status was:  Active, not recruiting
First Posted : July 17, 2009
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : October 2009
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00940940

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

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Responsible Party: Deepali Kumar, Assistant Professor of Medicine, University of Alberta Identifier: NCT00940940     History of Changes
Other Study ID Numbers: DKUA-001
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs