COVID Vaccine Immunity in Kidney Transplant Recipients

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End Stage Renal Disease Kidney Transplant; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Coronavirus (COVID-19) SARS-CoV-2 inSIGHT™ T Cell Immunity Test

Boosters will be given after month 3 after transplant, and the 2nd booster will be given 3 months after the first.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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mRNA COVID vaccine

Eligibility Criteria

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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