Skip to main content
OpenTrials
Completed

NCT Number: NCT05490342

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

SARS-CoV-2 Vaccination Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Tor Vergata

Roma, 00100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Diagnostic Test

Blood test to value the antibody response to vaccination

Primary outcomes

  1. Rate of positive antibody titer

    Time frame: Between 30 and 120 ± 15 days after the completion of the vaccination cycle

    > 0.8 U/mL

Secondary outcomes

  1. Rate of highly protective antibody titer

    Time frame: Between 30 and 120 ± 15 days after the completion of the vaccination cycle

    >100 BAU/mL

  2. Median antibody titer absolute value

    Time frame: Between 30 and 120 ± 15 days after the completion of the vaccination cycle

    BAU/mL

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2022
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.