COVID Vaccine Immunity in Kidney Transplant Recipients

Withdrawn

• Conditions: End Stage Renal Disease; Kidney Transplant; Complications

• Registration Number: NCT05387343
• Lead Sponsor: University of Alabama at Birmingham

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 Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-24
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-28
• Study Start: 2022-11
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COVID spike protein IgG and Tcell assay	month 12	transplant patient response to vaccine compared to response of patients not on immunosuppression
COVID spike protein Immunoglobulin G (IgG) and Tcell assay	pre-transplant	transplant patient response to vaccine compared to response of patients not on immunosuppression