Effect of SARS-CoV-2 Vaccination in Liver Transplant Recipients
NCT ID: NCT05490342
Last Updated: 2022-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
61 participants
OBSERVATIONAL
2022-04-01
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
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.
Blood test to value the antibody response to vaccination
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
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.
Blood test to value the antibody response to vaccination
Interventions
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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.
Blood test to value the antibody response to vaccination
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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University of Rome Tor Vergata
OTHER
Responsible Party
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Tommaso Maria Manzia
Associate Professor
Locations
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Policlinico Tor Vergata
Roma, , Italy
Countries
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Other Identifiers
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sperimentazioni PTV 71.22
Identifier Type: -
Identifier Source: org_study_id
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