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

Recruiting

• Conditions: Liver Transplant
• Interventions: Biological: COVID-19 Vaccine

• Registration Number: NCT05051605
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study Start: 2021-09-15
• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-21
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-11
• Last Update Posted: 2023-02-14
• Primary Completion: 2023-06-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age>18
• At least 3 month post transplantation

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaccinated group	COVID-19 Vaccine	Fifty living donor liver transplantation recipients on maintenance immunosuppressive regimen who would receive COVID-19 vaccine at least 3 months postoperatively.

Primary Outcome Measures

Name	Time	Method
Neutralizing antibody titer change 14 days after vaccination compared to baseline	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
Neutralizing antibody titer change 28 days post vaccination compared to baseline	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

Secondary Outcome Measures

Name	Time	Method
Interleukin-6 serum level	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
Incidence of confirmed coronavirus disease	28 days after whole course of vaccination	Patient follow-up for confirmed symptomatic infection by SARS-COV2 virus
Incidence of adverse events related to vaccine	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
Incidence of acute graft rejection	On 14 and 28 days post whole course vaccination	Follow-up for signs and symptoms of graft rejection
Immune response correlation to IL-18 genetic polymorphism	28 days post whole course vaccination	TaqMan®️ SNP genotyping assay of IL-18 gene (rs187238 and rs917997)
Immune response correlation to HLA DRB1 genetic polymorphism	28 days post whole course vaccination	TaqMan®️ SNP genotyping assay of HLA DRB1 gene (rs2647087)

Trial Locations

Locations (1)

Ain Shams center for organ transplantation (ASCOT), Ain shams university specialized hospital; 🇪🇬 Cairo, Please Select Region, State Or Province, Egypt