COVID19 Vaccine in SOT Adult Recipients (COVID19_VaxSOT)

April 1, 2024 updated by: Letizia Morlacchi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several studies indicate that solid organ transplant recipients are at increased risk of severe SARS-CoV2 disease (COVID19) and increased mortality from it (Pereira MR, AmJT 2020; Fernandez-Ruiz M, AmJT 2020; Kates OS, ClinInfectDis 2020).

Both ISHLT (International Society of Heart and Lung Transplantation) and AASLD (American Association for the Study of Liver Disease) guidelines recommend vaccination of all individuals undergoing lung and liver transplantation, starting from 3/6 months after transplantation.

In Italy, the Ministry of Health and the Italian Medicines Agency (AIFA) have established that immunosuppressed subjects following organ transplantation are worthy of vaccination with mRNA vaccines, since the latter are currently those with the greatest efficacy demonstrated among those approved in this country.

Within the Institution where this study will be conducted, patients undergoing lung and liver transplantation will be vaccinated, according to priority levels dictated by existing co-morbidities and by the time elapsed since transplantation, with the COMIRNATY mRNA vaccine (BNT162b2) administered according to the vaccination schedule of 2 doses at a distance of 21 days from each other or with the MODERNA vaccine (mRNA-1273) administered according to a vaccination schedule of 2 doses at a distance of 28 days from each other.

At present, no definitive data are available on the efficacy and the immunogenicity of anti-SARS-CoV-2 vaccines in solid organ transplant recipients, although the initial findings are reassuring. mRNA vaccines appear to be safe in the transplant population, and have not raised any concern at present about the possible onset of rejection or other serious adverse events in the first period after their administration (Boyarsky BJ, Transplantation 2021).

The primary objective of this study is to evaluate the safety and reactogenicity of antiSARS-CoV2 mRNA vaccines in SOT recipients.

Secondary outcomes include immunogenicity and efficacy (see Outcome paragraph for details).

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

Study Type

Observational

Enrollment (Actual)

364

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Lung and liver transplant recipients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LuTx recipients
Lung Transplant recipients
Biological: COVID19 mRNA vaccine
Administration of COVID19 mRNA vaccine
OLT recipients
Orthotopic Liver Transplant recipients
Biological: COVID19 mRNA vaccine
Administration of COVID19 mRNA vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and reactogenicity
Time Frame: 365 days

Primary endpoints:

  • Incidence of systemic and local adverse events (and their degree) in the subsequent 7 days after each vaccine administration in this population
  • Incidence of unusual adverse events (and their degree) in the subsequent 28 days after each vaccine administration in this population
  • Incidence of serious adverse events (SAEs) and sentinel events (NOCMCs, new onset chronic medical conditions, and MAAEs, medically-attended adverse events) over a 1-year follow-up period after administration of the first vaccine dose in this population
365 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity - antibody response, using ImmunoAssay in ECLIA for the quantitative detection of anti-protein S1 (spike) antibodies (including IgG)
Time Frame: 365 days
  • Geometric mean titer (GMT) of SARS-CoV2 anti-protein S1 total Ig (spike) antibody titers (GMT) at each timepoint
  • Percentage of individuals experiencing seroconversion at each timepoint
  • Increase of antibody titers (GMFR, geometric mean fold rise) from T0
365 days
Immunogenicity - Tcell response, using IGRA interferon-γ ELISpot, performed 60 days after the administration of the first vaccine dose
Time Frame: 60 days
- Evaluation of the IFN-γ ELISpot-mediated T-cell response for different stimuli (peptides of proteins S1, S2, N, M, E and mix of structural proteins), measured with the following unit of measurement, i.e. IFN -γ spots / 250,000 PBMC (peripheral blood mononuclear cell) for each stimulus, 60 days after the first vaccine dose
60 days
Prevention of COVID19
Time Frame: 365 days
- Incidence of SARS-CoV2 infection, diagnosed with positivity of nasopharyngeal swab (SARS-CoV2 RNA search with RT-Real time PCR method)
365 days
Prevention of severe COVID19
Time Frame: 365 days

To evaluate the actual prevention of severe forms of SARS-CoV2 infection in this population

- Incidence of severe forms of SARS-CoV2 infections, defined as requiring hospitalization of the patient and / or conditioning pneumonia / respiratory failure / sepsis / septic shock / ARDS
365 days
Immunogenicity and immunosuppression level
Time Frame: 365 days
To compare the obtained (both antibody and T cell mediated) immunogenicity with the immunosuppression levels
365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 11, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID19_VaxSOT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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