Liver Transplant
Conditions
Keywords
Liver, transplantation, COVID-19, Coronavirus, Vaccine
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.
Interventions
BIOLOGICALCOVID-19 Vaccine
Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2)vaccine according to vaccine availability in the Egyptian ministry of health.
Sponsors
Ain Shams University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| Incidence of confirmed coronavirus disease | 28 days after whole course of vaccination | Patient follow-up for confirmed symptomatic infection by SARS-COV2 virus |
Countries
Egypt
Contacts
Primary ContactRana Sayed, PhD
Backup ContactSara Alaa, Msc
Outcome results
None listed