End Stage Renal Disease, Kidney Transplant; Complications
Conditions
Keywords
COVID-19, kidney, kidney transplant, end stage renal disease, mRNA vaccine
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.
Interventions
DIAGNOSTIC_TESTCoronavirus (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.
Sponsors
ViraCor Laboratories
University of Alabama at Birmingham
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed