COVID Vaccine Immunity in Kidney Transplant Recipients

October 25, 2022 updated by: Graham C. Towns, University of Alabama at Birmingham
50 end-stage renal disease (ESRD) patients whom have had at least 2 doses of messenger ribonucleic acid (mRNA) vaccine, and undergoing transplantation at the University of Alabama at Birmingham (UAB) will be enrolled. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

50 ESRD patients on peritoneal dialysis or hemodialysis or not on immunosuppression, no prior transplant, no known history of COVID infection, whom have had at least 2 doses of mRNA vaccine, and undergoing transplantation at UAB will be enrolled, after signing the informed consent. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.

Study Type

Observational

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients planning on having a renal transplant at the University of Alabama at Birmingham

Description

Inclusion Criteria:

  • End Stage Renal Disease patients on peritoneal dialysis or hemodialysis or not on immunosuppression
  • no prior transplant
  • no known history of COVID infection
  • had at least 2 doses of mRNA COVID vaccine
  • undergoing transplantation at the University of Alabama at Birmingham
  • multi-organ transplant allowed

Exclusion Criteria:

  • active COVID infection
  • participant is not vaccinated against COVID

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID spike protein Immunoglobulin G (IgG) and Tcell assay
Time Frame: pre-transplant
transplant patient response to vaccine compared to response of patients not on immunosuppression
pre-transplant
COVID spike protein IgG and Tcell assay
Time Frame: month 1
transplant patient response to vaccine compared to response of patients not on immunosuppression
month 1
COVID spike protein IgG and Tcell assay
Time Frame: month 3
transplant patient response to vaccine compared to response of patients not on immunosuppression
month 3
COVID spike protein IgG and Tcell assay
Time Frame: month 4
transplant patient response to vaccine compared to response of patients not on immunosuppression
month 4
COVID spike protein IgG and Tcell assay
Time Frame: month 6
transplant patient response to vaccine compared to response of patients not on immunosuppression
month 6
COVID spike protein IgG and Tcell assay
Time Frame: month 12
transplant patient response to vaccine compared to response of patients not on immunosuppression
month 12

Collaborators and Investigators

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

Sponsor

University of Alabama at Birmingham

Collaborators

ViraCor Laboratories

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 (ANTICIPATED)

November 1, 2022

Primary Completion (ANTICIPATED)

November 1, 2024

Study Completion (ANTICIPATED)

November 1, 2024

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (ACTUAL)

May 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCT2022.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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