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

Completed

• Conditions: Liver Transplantation; SARS-CoV-2 Vaccination
• 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.

• Registration Number: NCT05490342
• Lead Sponsor: University of Rome Tor Vergata

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study First Posted: 2022-08-05
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tacrolimus-based immunosuppresion	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.	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	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.	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Policlinico Tor Vergata; 🇮🇹 Roma, Italy