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

Overview

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.

Full Title of Study: “Evaluation of SARS-CoV-2 Antibody Response After Vaccination in Liver Transplant Recipients Who Undergo Tailored Immunosuppression Therapy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 30, 2022

Interventions

  • 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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Rome Tor Vergata
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tommaso Maria Manzia, Associate Professor – University of Rome Tor Vergata

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