Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
A prospective cohort study to evaluate the response to COVID-19 vaccine in liver transplantation patients.

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluation of the Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation

Conditions
-----------------
Liver Transplant

Intervention / Treatment
-----------------
* Biological: COVID-19 Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 At least 3 month post transplantation Exclusion Criteria: pediatric recipients Active covid infection at the time of the study Pregnancy Allergy to any ingredients included in the vaccine Lactation in first six month of delivery Active Acute cellular rejection proven by liver biopsy Acute Febrile state with either leucopenia or leucocytosis High dose of corticosteroid at study timing (pulse methyl prednisolone)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccinated group<br>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<br>* Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2)vaccine according to vaccine availability in the Egyptian ministry of health.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | At baseline and 28 days after whole course of vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 serum level | Assessing the cellular immunological response to SARS-CoV-2 vaccine in recipients post living donor liver transplantation | 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 | 28 days after whole course of vaccination | 
| Incidence of adverse events related to vaccine | Self reported safety and tolerability of vaccine | 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 | 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) | 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) | 28 days post whole course vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver, transplantation, COVID-19, Coronavirus, Vaccine