Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation
This trial is active, not recruiting.
|Treatments||zostavax (live attenuated herpes zoster vaccine), placebo vaccine|
|Sponsor||University of Alberta|
|Start date||October 2009|
|End date||June 2016|
|Trial size||40 participants|
|Trial identifier||NCT00940940, DKUA-001|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver, investigator)|
time frame: 6 months
Male or female participants from 18 years up to 65 years old.
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
|Official title||Safety and Immunogenicity of Live Attenuated Herpes Zoster Vaccine in Patients Undergoing Living Donor Kidney Transplantations|
|Principal investigator||Deepali Kumar, MD|
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