Liver TransplantNCT05051605
Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation
An observational study of Liver Transplant, run by Ain Shams University at 1 site in Egypt.
Trial summary
A prospective cohort study to evaluate the response to COVID-19 vaccine in liver transplantation patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2021to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age>18
- At least 3 month post transplantation
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams center for organ transplantation (ASCOT), Ain shams university specialized hospital
Cairo, Please Select Region, State Or Province, 11765
Rana Sayed, PhD, 01208164247 ext. +2, ranasayed@pharma.asu.edu.eg
About this study
Official title: Evaluation of the Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation
A prospective cohort study to evaluate the response to COVID-19 vaccine in liver transplantation patients.
Read the 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.
- Conditions
- Liver Transplant
- Being tested
- COVID-19 Vaccine
- Keywords
- Liver, transplantation, COVID-19, Coronavirus, Vaccine
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccineBiological
Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2)vaccine according to vaccine availability in the Egyptian ministry of health.
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated group | Fifty living donor liver transplantation recipients on maintenance immunosuppressive regimen who would receive COVID-19 vaccine at least 3 months postoperatively. Receives: Biological: COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At baseline and 28 days after whole course of vaccination
Secondary outcomes (6)
Interleukin-6 serum level
Assessing the cellular immunological response to SARS-CoV-2 vaccine in recipients post living donor liver transplantation
Measured: At baseline, at 14 and 28 days after whole course of vaccination
Incidence of confirmed coronavirus disease
Patient follow-up for confirmed symptomatic infection by SARS-COV2 virus
Measured: 28 days after whole course of vaccination
Incidence of adverse events related to vaccine
Self reported safety and tolerability of vaccine
Measured: 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
Measured: 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)
Measured: 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)
Measured: 28 days post whole course vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start15 Sep 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Sayed Fouad, Ain Shams University
- Investigators
- Rana Sayed, PhD, Study director, Faculty of Pharmacy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051605
- Sponsor's protocol ID
- RHDIRB2020110301 REC 45
- Status last verified
- Feb 2023
- First submitted
- 17 Sep 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT05051605
- Acronym / sponsor ID
- RHDIRB2020110301 REC 45
- Conditions
- Liver Transplant
- Keywords
- Liver, transplantation, COVID-19, Coronavirus, Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccinated group | – | Biological: COVID-19 VaccineFifty living donor liver transplantation recipients on maintenance immunosuppressive regimen who would receive COVID-19 vaccine at least 3 months postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Age>18
- At least 3 month post transplantation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 VaccineSevere acute respiratory syndrome- coronavirus-2 (SARS-CoV-2)vaccine according to vaccine availability in the Egyptian ministry of health. | Biological | Vaccinated group |
Primary outcome
Neutralizing antibody titer change 14 days after vaccination compared to baseline
Time frame: 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
Time frame: 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
6 secondary outcomes
Interleukin-6 serum level
Time frame: At baseline, at 14 and 28 days after whole course of vaccination
Incidence of confirmed coronavirus disease
Time frame: 28 days after whole course of vaccination
Incidence of adverse events related to vaccine
Time frame: 7 days after each dose of the vaccine and up to 28 days after last vaccine dose administered
Incidence of acute graft rejection
Time frame: On 14 and 28 days post whole course vaccination
Immune response correlation to HLA DRB1 genetic polymorphism
Time frame: 28 days post whole course vaccination
Immune response correlation to IL-18 genetic polymorphism
Time frame: 28 days post whole course vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
Related trials for Liver Transplant
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana Sayed, PhD study director
Faculty of Pharmacy, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana Sayed, PhD (01208164247 ext. +2, ranasayed@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutralizing antibody titer change 14 days after vaccination compared to baseline (time frame: At baseline, at 14 days after whole course of vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.