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CompletedNCT00940940Updated Jun 1, 2022

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

A Phase 4 interventional study of Zostavax (Live attenuated herpes zoster vaccine) and Placebo vaccine in Kidney Transplant, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by University of Alberta · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Transplant
03

In context

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

  1. Previous receipt of Zostavax
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Live attenuated herpes zoster vaccine

    Biological: Zostavax (Live attenuated herpes zoster vaccine)

  • Placebo comparator
    Placebo

    Biological: Placebo vaccine

Interventions

  • BiologicalZostavax (Live attenuated herpes zoster vaccine)

    0.6 mL subcutaneous

    Also known as: Zostavax

  • BiologicalPlacebo vaccine

    0.65 mL subcutaneous

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What researchers measure

Primary outcomes

  1. Immunogenicity

    Time frame: 6 months

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Study locations

1 site
  • University of Alberta Hospital
    Edmonton, Alberta, Canada
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00940940
Lead sponsor
University of Alberta
Responsible party
Sponsor
First posted
Jul 17, 2009
Start date
Oct 2009
Primary completion
Aug 26, 2013
Completion
Sep 23, 2013
Last update
Jun 1, 2022

Study contacts

Deepali Kumar, MD
principal investigator · University of Alberta

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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