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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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