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

February 11, 2023 updated by: Rana Sayed Fouad, Ain Shams University

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

A prospective cohort study to evaluate the response to COVID-19 vaccine in liver transplantation patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Please Select Region, State Or Province
      • Cairo, Please Select Region, State Or Province, Egypt, 11765
        • Recruiting
        • Ain Shams center for organ transplantation (ASCOT), Ain shams university specialized hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Living donor liver transplantation recipients willing to be vaccinated against COVID-19 and capable of signing an informed consent to participate in this cohort

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccinated group
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.

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
Time Frame: At baseline, at 14 days after whole course of vaccination
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
Time Frame: At baseline and 28 days after whole course of vaccination
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
Time Frame: At baseline, at 14 and 28 days after whole course of vaccination
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
Time Frame: 28 days after whole course of vaccination
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
Time Frame: 7 days after each dose of the vaccine and up to 28 days after last vaccine dose administered
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
Time Frame: On 14 and 28 days post whole course vaccination
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
Time Frame: 28 days post whole course vaccination
TaqMan®️ SNP genotyping assay of HLA DRB1 gene (rs2647087)
28 days post whole course vaccination
Immune response correlation to IL-18 genetic polymorphism
Time Frame: 28 days post whole course vaccination
TaqMan®️ SNP genotyping assay of IL-18 gene (rs187238 and rs917997)
28 days post whole course vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2021

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

November 30, 2023

Study Registration Dates

First Submitted

September 17, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (ACTUAL)

September 21, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 11, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHDIRB2020110301 REC 45

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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