COVID Vaccine Immunity in Kidney Transplant Recipients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End Stage Renal Disease
- Sponsor
- University of Alabama at Birmingham
- Primary Endpoint
- COVID spike protein IgG and Tcell assay
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Graham C. Towns
Associate Professor
University of Alabama at Birmingham
Eligibility Criteria
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
Outcomes
Primary Outcomes
COVID spike protein IgG and Tcell assay
Time Frame: month 12
transplant patient response to vaccine compared to response of patients not on immunosuppression
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