COVID Vaccine Immunity in Kidney Transplant Recipients

The University of Alabama at Birmingham

Status: Withdrawn

Conditions: Kidney Transplant; Complications; End Stage Renal Disease

Treatments: Diagnostic Test: Coronavirus (COVID-19) SARS-CoV-2 inSIGHT™ T Cell Immunity Test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05387343

GCT2022.001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

• active COVID infection
• participant is not vaccinated against COVID