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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05490342

Enrollment

Registered

2022-08-05

Start date

2022-04-01

Completion date

2022-06-30

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation, SARS-CoV-2 Vaccination

Brief summary

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.

Interventions

DIAGNOSTIC_TESTImmunoassay, 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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026