Effect of SARS-CoV-2 Vaccination in Liver Transplant Recipients
Completed
- Conditions
- Liver TransplantationSARS-CoV-2 Vaccination
- 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
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
- 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
Policlinico Tor Vergata🇮🇹Roma, Italy