Assessment of VZV-specific ELISPOT Assay for Predicting VZV Infection in Kidney Transplant Recipients (AVE-KT)

August 28, 2018 updated by: Sung-Han Kim, Asan Medical Center
VZV is one of the important opportunistic infection in transplant recipients.Until now, there is no laboratory method to stratify the risk of VZV reactivation after solid organ transplantation. Theoretically, VZV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of VZV development after solid organ transplantation. The investigators thus evaluate the usefulness of VZV-specific ELISPOT assay in kidney transplant candidates to predict the development of VZV infection after kidney transplantation.

Study Overview

Status

Terminated

Conditions

Detailed Description

We will develop VZV-specific ELISPOT assay, then perform this assay before transplantation. We will evaluate whether this assay will predict zoster reactivation after transplantation.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Kindeny transplant recipients

Description

Inclusion Criteria:

  • age 16 years or more
  • agree with written informed consent
  • WBC count 2000/uL or more

Exclusion Criteria:

  • no exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
high VZV ELISPOT results
high spot counts in ELISPOT
low VZV ELISPOT results
low spot counts in ELISPOT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
zoster development
Time Frame: 6 months after transplantation
6 months after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 6 months after transplantation
6 months after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Korea Advanced Institute of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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