NCT05051605

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

September 17, 2021

Last Update Submit

February 11, 2023

Conditions

Liver Transplant

Keywords

LivertransplantationCOVID-19CoronavirusVaccine

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (6)

  • Interleukin-6 serum level

    At baseline, at 14 and 28 days after whole course of vaccination

  • Incidence of confirmed coronavirus disease

    28 days after whole course of vaccination

  • 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

  • Incidence of acute graft rejection

    On 14 and 28 days post whole course vaccination

  • Immune response correlation to HLA DRB1 genetic polymorphism

    28 days post whole course vaccination

  • +1 more secondary outcomes

Study Arms (1)

Vaccinated group

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

Biological: COVID-19 Vaccine

Interventions

COVID-19 VaccineBIOLOGICAL

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

Vaccinated group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Age\>18
  • At least 3 month post transplantation

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Please Select Region, State Or Province, 11765, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Rana Sayed, PhD

    Faculty of Pharmacy, Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Rana Sayed, PhD

CONTACT

01208164247ranasayed@pharma.asu.edu.eg

Sara Alaa, Msc

CONTACT

01112119264Sarah_alaaosman52@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 21, 2021

Study Start

September 15, 2021

Primary Completion

June 30, 2023

Study Completion

November 30, 2023

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations

EG(1)