Effect of SARS-CoV-2 Vaccination in Liver Transplant Recipients

Evaluation of SARS-CoV-2 Antibody Response After Vaccination in Liver Transplant Recipients Who Undergo Tailored Immunosuppression Therapy

To investigate the variations in the humoral response to vaccines for the prevention of COVID-19 in liver transplant patients based on the type of immunosuppressive therapy adopted (tacrolimus based vs no-tacrolimus based) and immunosuppressive blood levels.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation; SARS-CoV-2 Vaccination
• Intervention / Treatment: Diagnostic test: Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00100
    • Policlinico Tor Vergata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Liver transplant recipients who underwent SARS-CoV-2 vaccination (3 doses)

Description

Inclusion Criteria:

• Liver transplanted patients >18 years of age.
• Patients who underwent liver transplantation between 01/2015 to 12/2021.
• Patients who underwent liver transplantation at "Policlinico Tor Vergata, Rome, Italy".
• Patients who have had three doses of a vaccine for the prevention of COVID-19.
• Patients who have had three doses of a SARS-CoV-2 vaccine and who have contracted SARS-CoV-2 infection.

Exclusion Criteria:

• Patients who have more or less than three dose of a vaccine for the prevention of COVID-19
• Patients not vaccinated for prevention of SARS-CoV-2 infection.
• Patients who have had three doses of a vaccine for the prevention of COVID-19 prior to liver transplantation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
tacrolimus-based immunosuppresion; The TAC-based group will include any patient on tacrolimus monotherapy and patients taking multiple IS medications with blood tacrolimus levels > 5 ng/mL	Diagnostic test: Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.; Blood test to value the antibody response to vaccination
NON-tacrolimus-based immunosuppresion; The NON-TAC-based group will include any patient on TAC-free therapy and patient taking multiple IS medications with blood tacrolimus levels < 5 ng/mL	Diagnostic test: Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.; Blood test to value the antibody response to vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of positive antibody titer	> 0.8 U/mL	Between 30 and 120 ± 15 days after the completion of the vaccination cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of highly protective antibody titer	>100 BAU/mL	Between 30 and 120 ± 15 days after the completion of the vaccination cycle
Median antibody titer absolute value	BAU/mL	Between 30 and 120 ± 15 days after the completion of the vaccination cycle

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies; Myeloma Proteins; Paraproteins
• Other Study ID Numbers: sperimentazioni PTV 71.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No