COVID Vaccine Immunity in Kidney Transplant Recipients

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05387343

Collaborator

ViraCor Laboratories (Industry)

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease Kidney Transplant; Complications	Diagnostic Test: Coronavirus (COVID-19) SARS-CoV-2 inSIGHT™ T Cell Immunity Test

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

COVID Vaccine Immunity in Kidney Transplant Recipients

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Outcome Measures

Primary Outcome Measures

COVID spike protein Immunoglobulin G (IgG) and Tcell assay [pre-transplant]
transplant patient response to vaccine compared to response of patients not on immunosuppression
COVID spike protein IgG and Tcell assay [month 1]
transplant patient response to vaccine compared to response of patients not on immunosuppression
COVID spike protein IgG and Tcell assay [month 3]
transplant patient response to vaccine compared to response of patients not on immunosuppression
COVID spike protein IgG and Tcell assay [month 4]
transplant patient response to vaccine compared to response of patients not on immunosuppression
COVID spike protein IgG and Tcell assay [month 6]
transplant patient response to vaccine compared to response of patients not on immunosuppression
COVID spike protein IgG and Tcell assay [month 12]
transplant patient response to vaccine compared to response of patients not on immunosuppression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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