COVID Vaccine Immunity in Kidney Transplant Recipients

Study Overview
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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.

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.

Official Title
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COVID Vaccine Immunity in Kidney Transplant Recipients

Conditions
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End Stage Renal Disease, Kidney Transplant; Complications

Intervention / Treatment
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* Diagnostic Test: Coronavirus (COVID-19) SARS-CoV-2 inSIGHT™ T Cell Immunity Test


Participation Criteria
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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 Exclusion Criteria: active COVID infection participant is not vaccinated against COVID

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 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.|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end stage renal disease, mRNA vaccine, COVID-19, kidney, kidney transplant