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COVID19 Vaccine in SOT Adult Recipients

NCT05116748 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 364

Last updated 2024-04-02

No results posted yet for this study

Summary

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

Conditions

  • COVID-19
  • Vaccine Adverse Reaction
  • Vaccine Response Impaired
  • Vaccine Reaction
  • Lung Transplant; Complications
  • Liver Transplant; Complications
  • Vaccination

Interventions

BIOLOGICAL

COVID19 mRNA vaccine

Administration of COVID19 mRNA vaccine

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Letizia Corinna Morlacchi, MD · Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-12-30
Completion
2023-12-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05116748 on ClinicalTrials.gov