Safety and Immunogenicity of the SARS-CoV2 Vaccine in Solid Organ Transplantation (Lung and / or Liver) Adult Recipients

COVID19_VaxSOT

Background: ISHLT and AASLD guidelines recommend SARS-CoV2 vaccination in all individuals undergoing lung and liver transplantation, but there are currently scarce data on the safety and efficacy of these vaccines in this population. In Italy, immunocompromised patients have received the indication to be administered mRNA vaccines only. Primary outcome: safety and reactogenicity Secondary outcomes: immunogenicity and prevention of COVID19 Visits and timepoints: * T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status * Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination * T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity * Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity

2021-10-01

2022-12-30

2023-12-31

Completed

364

Inclusion Criteria: * Age \> 18 years * Patient's written informed consent Exclusion Criteria: * Lung transplant being performed in the previous 6 months * Liver transplant being performed in the previous 3 months

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 364, 'type': 'ACTUAL'}}

2024-04-02