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

NCT ID: NCT05051605

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vaccinated group

Fifty living donor liver transplantation recipients on maintenance immunosuppressive regimen who would receive COVID-19 vaccine at least 3 months postoperatively.

COVID-19 Vaccine

Intervention Type BIOLOGICAL

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

Interventions

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COVID-19 Vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Rana Sayed Fouad

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rana Sayed, PhD

Role: STUDY_DIRECTOR

Faculty of Pharmacy, Ain Shams University

Locations

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Ain Shams center for organ transplantation (ASCOT), Ain shams university specialized hospital

Cairo, Please Select Region, State Or Province, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rana Sayed, PhD

Role: CONTACT

01208164247 ext. +2

Sara Alaa, Msc

Role: CONTACT

01112119264 ext. +2

Facility Contacts

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Rana Sayed, PhD

Role: primary

01208164247 ext. +2

Other Identifiers

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RHDIRB2020110301 REC 45

Identifier Type: -

Identifier Source: org_study_id

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