Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. | Diagnostic Test | Blood test to value the antibody response to vaccination |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Liver transplant recipients who underwent SARS-CoV-2 vaccination (3 doses)
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Tor Vergata | Roma | 00100 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Between 30 and 120 ± 15 days after the completion of the vaccination cycle |