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

NCT ID: NCT00940940

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-09-23

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Live attenuated herpes zoster vaccine

Group Type EXPERIMENTAL

Zostavax (Live attenuated herpes zoster vaccine)

Intervention Type BIOLOGICAL

0.6 mL subcutaneous

Placebo

Group Type PLACEBO_COMPARATOR

Placebo vaccine

Intervention Type BIOLOGICAL

0.65 mL subcutaneous

Interventions

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Zostavax (Live attenuated herpes zoster vaccine)

0.6 mL subcutaneous

Intervention Type BIOLOGICAL

Placebo vaccine

0.65 mL subcutaneous

Intervention Type BIOLOGICAL

Other Intervention Names

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Zostavax

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deepali Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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DKUA-001

Identifier Type: -

Identifier Source: org_study_id

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