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

NCT05490342 | Completed

• 1 other identifier: sperimentazioni PTV 71.22
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Vaccination; Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Rate of positive antibody titer

  \> 0.8 U/mL

  Between 30 and 120 ± 15 days after the completion of the vaccination cycle

Secondary Outcomes (2)

• Rate of highly protective antibody titer

  Between 30 and 120 ± 15 days after the completion of the vaccination cycle

• Median antibody titer absolute value

  Between 30 and 120 ± 15 days after the completion of the vaccination cycle

Study Arms (2)

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.

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.

Interventions

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

NON-tacrolimus-based immunosuppresion; tacrolimus-based immunosuppresion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Policlinico Tor Vergata

Roma, 00100, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 5, 2022
• Study Start: April 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)