Clinical trial NCT05051605: Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation
Official title: Evaluation of the Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant
Keywords: Liver
transplantation
COVID-19
Coronavirus
Vaccine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Living donor liver transplantation recipients willing to be vaccinated against COVID-19 and capable of signing an informed consent to participate in this cohort

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Neutralizing antibody titer change 14 days after vaccination compared to baseline
timeFrame: At baseline, at 14 days after whole course of vaccination
measure: Neutralizing antibody titer change 28 days post vaccination compared to baseline
timeFrame: At baseline and 28 days after whole course of vaccination
Secondary outcomes:
measure: Interleukin-6 serum level
timeFrame: At baseline, at 14 and 28 days after whole course of vaccination
measure: Incidence of confirmed coronavirus disease
timeFrame: 28 days after whole course of vaccination
measure: Incidence of adverse events related to vaccine
timeFrame: 7 days after each dose of the vaccine and up to 28 days after last vaccine dose administered
measure: Incidence of acute graft rejection
timeFrame: On 14 and 28 days post whole course vaccination
measure: Immune response correlation to HLA DRB1 genetic polymorphism
timeFrame: 28 days post whole course vaccination
measure: Immune response correlation to IL-18 genetic polymorphism
timeFrame: 28 days post whole course vaccination
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams center for organ transplantation (ASCOT), Ain shams university specialized hospital
state: Please Select Region, State Or Province
Study officials:
affiliation: Faculty of Pharmacy, Ain Shams University
name: Rana Sayed, PhD
role: STUDY_DIRECTOR
References: