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

Ain Shams University50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Transplant

Interventions

COVID-19 VaccineBIOLOGICAL

Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2)vaccine according to vaccine availability in the Egyptian ministry of health.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Ain Shams center for organ transplantation (ASCOT), Ain shams university specialized hospital

Cairo, Please Select Region, State Or Province, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Central Contacts

Rana Sayed, PhD

CONTACT

01208164247 ranasayed@pharma.asu.edu.eg

Sara Alaa, Msc

CONTACT

01112119264 Sarah_alaaosman52@hotmail.com

Data from ClinicalTrials.gov

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