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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05051605
Other study ID # RHDIRB2020110301 REC 45
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 15, 2021
Est. completion date November 30, 2023

Study information

Verified date February 2023
Source Ain Shams University
Contact Rana Sayed, PhD
Phone 01208164247
Email ranasayed@pharma.asu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
COVID-19 Vaccine
Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2)vaccine according to vaccine availability in the Egyptian ministry of health.

Locations

Country Name City State
Egypt Ain Shams center for organ transplantation (ASCOT), Ain shams university specialized hospital Cairo Please Select Region, State Or Province

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary Incidence of confirmed coronavirus disease Patient follow-up for confirmed symptomatic infection by SARS-COV2 virus 28 days after whole course of vaccination
Secondary 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
Secondary Incidence of acute graft rejection Follow-up for signs and symptoms of graft rejection On 14 and 28 days post whole course vaccination
Secondary Immune response correlation to HLA DRB1 genetic polymorphism TaqMan®? SNP genotyping assay of HLA DRB1 gene (rs2647087) 28 days post whole course vaccination
Secondary 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
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