COVID Vaccine Immunity in Kidney Transplant Recipients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- COVID spike protein IgG and Tcell assay
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Graham C. Towns
Associate Professor
University of Alabama at Birmingham