Liver Transplantation Clinical Trial
Official title:
Evaluation of SARS-CoV-2 Antibody Response After Vaccination in Liver Transplant Recipients Who Undergo Tailored Immunosuppression Therapy
Verified date | August 2022 |
Source | University of Rome Tor Vergata |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 61 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Tor Vergata | Roma |
Lead Sponsor | Collaborator |
---|---|
University of Rome Tor Vergata |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of positive antibody titer | > 0.8 U/mL | Between 30 and 120 ± 15 days after the completion of the vaccination cycle | |
Secondary | Rate of highly protective antibody titer | >100 BAU/mL | Between 30 and 120 ± 15 days after the completion of the vaccination cycle | |
Secondary | Median antibody titer absolute value | BAU/mL | Between 30 and 120 ± 15 days after the completion of the vaccination cycle |
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