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

Liver Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051605
• Other study ID #: RHDIRB2020110301 REC 45
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• COVID-19
• Liver Transplant

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