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

University of Rome Tor Vergata

Status: Completed

Conditions: Liver Transplantation; SARS-CoV-2 Vaccination

Treatments: 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

Funder types: Other

Identifiers

NCT05490342

sperimentazioni PTV 71.22

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

61 participants in 2 patient groups

tacrolimus-based immunosuppresion

Description:

The TAC-based group will include any patient on tacrolimus monotherapy and patients taking multiple IS medications with blood tacrolimus levels \> 5 ng/mL

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.

NON-tacrolimus-based immunosuppresion

Description:

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

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.