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A prospective cohort study to evaluate the response to COVID-19 vaccine in liver transplantation patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccinated group | Fifty living donor liver transplantation recipients on maintenance immunosuppressive regimen who would receive COVID-19 vaccine at least 3 months postoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Vaccine | Biological | Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2)vaccine according to vaccine availability in the Egyptian ministry of health. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence of confirmed coronavirus disease |
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Inclusion Criteria:
Exclusion Criteria:
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Living donor liver transplantation recipients willing to be vaccinated against COVID-19 and capable of signing an informed consent to participate in this cohort
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rana Sayed, PhD | Contact | 01208164247 | +2 | ranasayed@pharma.asu.edu.eg |
| Sara Alaa, Msc | Contact | 01112119264 | +2 | Sarah_alaaosman52@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rana Sayed, PhD | Faculty of Pharmacy, Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams center for organ transplantation (ASCOT), Ain shams university specialized hospital | Recruiting | Cairo | Please Select Region, State Or Province | 11765 | Egypt |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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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 | 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 | 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 | TaqMan®️ SNP genotyping assay of HLA DRB1 gene (rs2647087) | 28 days post whole course vaccination |
| 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 |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |