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

Liver Transplantation Clinical Trial

Official title:

Evaluation of SARS-CoV-2 Antibody Response After Vaccination in Liver Transplant Recipients Who Undergo Tailored Immunosuppression Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05490342
• Other study ID #: sperimentazioni PTV 71.22
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

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.
Blood test to value the antibody response to vaccination

Locations

Country	Name	City	State
Italy	Policlinico Tor Vergata	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

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