NCT05387343

COVID Vaccine Immunity in Kidney Transplant Recipients

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease
• Kidney Transplant; Complications

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coronavirus (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.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2022-05-24
• Last updated: 2022-10-28