COVID Vaccine Immunity in Kidney Transplant Recipients

End Stage Renal Disease Clinical Trial

Official title:

COVID Vaccine Immunity in Kidney Transplant Recipients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05387343
• Other study ID #: GCT2022.001
• Status: Withdrawn
• Start date: November 2022
• Est. completion date: November 2024

Study information

• Verified date: October 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Kidney Transplant; Complications

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	ViraCor Laboratories

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID spike protein Immunoglobulin G (IgG) and Tcell assay	transplant patient response to vaccine compared to response of patients not on immunosuppression	pre-transplant
Primary	COVID spike protein IgG and Tcell assay	transplant patient response to vaccine compared to response of patients not on immunosuppression	month 1
Primary	COVID spike protein IgG and Tcell assay	transplant patient response to vaccine compared to response of patients not on immunosuppression	month 3
Primary	COVID spike protein IgG and Tcell assay	transplant patient response to vaccine compared to response of patients not on immunosuppression	month 4
Primary	COVID spike protein IgG and Tcell assay	transplant patient response to vaccine compared to response of patients not on immunosuppression	month 6
Primary	COVID spike protein IgG and Tcell assay	transplant patient response to vaccine compared to response of patients not on immunosuppression	month 12