Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|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
- Immunogenicity [ Time Frame: 6 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00940940
|University of Alberta Hospital|
|Edmonton, Alberta, Canada|
|Principal Investigator:||Deepali Kumar, MD||University of Alberta|