An observational study in Liver Transplant, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by Ain Shams University · Observational
A prospective cohort study to evaluate the response to COVID-19 vaccine in liver transplantation patients.
fifty living donor liver transplantation recipients during maintenance immunosuppression phase will be vaccinated against COVID-19 followed by assessment of immune response to the vaccine and further investigation of correlation of immune response to genetic polymorphisms of HLA DRB1(rs2647087) gene and IL-18 (rs187238 and rs917997) gene.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 50 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Living donor liver transplantation recipients willing to be vaccinated against COVID-19 and capable of signing an informed consent to participate in this cohort
Exclusion Criteria:
Fifty living donor liver transplantation recipients on maintenance immunosuppressive regimen who would receive COVID-19 vaccine at least 3 months postoperatively.
Biological: COVID-19 Vaccine
Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2)vaccine according to vaccine availability in the Egyptian ministry of health.
Neutralizing antibody titer change 14 days after vaccination compared to baseline
neutralizing antibody response to SARS-CoV-2 vaccine in recipients post living donor liver transplantation
Time frame: At baseline, at 14 days after whole course of vaccination
Neutralizing antibody titer change 28 days post vaccination compared to baseline
neutralizing antibody response to SARS-CoV-2 vaccine in recipients post living donor liver transplantation
Time frame: At baseline and 28 days after whole course of vaccination
Interleukin-6 serum level
Assessing the cellular immunological response to SARS-CoV-2 vaccine in recipients post living donor liver transplantation
Time frame: At baseline, at 14 and 28 days after whole course of vaccination
Incidence of confirmed coronavirus disease
Patient follow-up for confirmed symptomatic infection by SARS-COV2 virus
Time frame: 28 days after whole course of vaccination
Incidence of adverse events related to vaccine
Self reported safety and tolerability of vaccine
Time frame: 7 days after each dose of the vaccine and up to 28 days after last vaccine dose administered
Incidence of acute graft rejection
Follow-up for signs and symptoms of graft rejection
Time frame: On 14 and 28 days post whole course vaccination
Immune response correlation to HLA DRB1 genetic polymorphism
TaqMan®️ SNP genotyping assay of HLA DRB1 gene (rs2647087)
Time frame: 28 days post whole course vaccination
Immune response correlation to IL-18 genetic polymorphism
TaqMan®️ SNP genotyping assay of IL-18 gene (rs187238 and rs917997)
Time frame: 28 days post whole course vaccination
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Ain Shams University