COVID19 Vaccine in SOT Adult Recipients

NCT ID: NCT05116748

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 364 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-12-31

Brief 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

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

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

LuTx recipients

Lung Transplant recipients

COVID19 mRNA vaccine

Intervention Type: BIOLOGICAL

Administration of COVID19 mRNA vaccine

OLT recipients

Orthotopic Liver Transplant recipients

COVID19 mRNA vaccine

Intervention Type: BIOLOGICAL

Administration of COVID19 mRNA vaccine

Interventions

COVID19 mRNA vaccine

Administration of COVID19 mRNA vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Letizia Morlacchi

Principal Investigator; Respiratory Consultant, attending Lung Transplant clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Letizia Corinna Morlacchi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, , Italy

Countries

Italy

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Related Links

https://www.aifa.gov.it/vaccini-covid-19

Agenzia Italiana del Farmaco.

https://www.salute.gov.it/portale/home.html

Ministero della Salute del Governo Italiano

https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf

Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

https://www.who.int/emergencies/diseases/novel-coronavirus-2019

World Health Organization

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

NY Times vaccine tracker

Other Identifiers

COVID19_VaxSOT

Identifier Type: -

Identifier Source: org_study_id