COVID Vaccine Immunity in Kidney Transplant Recipients

NCT05387343 | Withdrawn

• 1 other identifier: GCT2022.001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End Stage Renal Disease; Kidney Transplant; Complications

Keywords

COVID-19; kidney; kidney transplant; end stage renal disease; mRNA vaccine

Outcome Measures

Primary Outcomes (6)

• COVID spike protein Immunoglobulin G (IgG) and Tcell assay

  transplant patient response to vaccine compared to response of patients not on immunosuppression

  pre-transplant

• COVID spike protein IgG and Tcell assay

  transplant patient response to vaccine compared to response of patients not on immunosuppression

  month 1

• COVID spike protein IgG and Tcell assay

  transplant patient response to vaccine compared to response of patients not on immunosuppression

  month 3

• COVID spike protein IgG and Tcell assay

  transplant patient response to vaccine compared to response of patients not on immunosuppression

  month 4

• COVID spike protein IgG and Tcell assay

  transplant patient response to vaccine compared to response of patients not on immunosuppression

  month 6

• COVID spike protein IgG and Tcell assay

  transplant patient response to vaccine compared to response of patients not on immunosuppression

  month 12

Interventions

Coronavirus (COVID-19) SARS-CoV-2 inSIGHT™ T Cell Immunity Test DIAGNOSTIC_TEST

Boosters will be given after month 3 after transplant, and the 2nd booster will be given 3 months after the first.

Also known as: mRNA COVID vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients planning on having a renal transplant at the University of Alabama at Birmingham

You may qualify if:

• 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

You may not qualify if:

• active COVID infection
• participant is not vaccinated against COVID

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• ViraCor Laboratories: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

blood samples will be collected for spike protein antibodies and t cell assays

MeSH Terms

Conditions

Kidney Failure, Chronic; COVID-19

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Graham C Towns, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share