Clinical trial NCT05116748: COVID19 Vaccine in SOT Adult Recipients
Official title: Safety and Immunogenicity of the SARS-CoV2 Vaccine in Solid Organ Transplantation (Lung and / or Liver) Adult Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Vaccine Adverse Reaction
Vaccine Response Impaired
Vaccine Reaction
Lung Transplant; Complications
Liver Transplant; Complications
Vaccination
Keywords: COVID19
Vaccination
Vaccine
Transplant
Solid organ transplant
Lung transplant
Liver transplant
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lung and liver transplant recipients

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

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

Primary outcomes:
measure: Safety and reactogenicity
timeFrame: 365 days
Secondary outcomes:
measure: Immunogenicity - antibody response, using ImmunoAssay in ECLIA for the quantitative detection of anti-protein S1 (spike) antibodies (including IgG)
timeFrame: 365 days
measure: Immunogenicity - Tcell response, using IGRA interferon-γ ELISpot, performed 60 days after the administration of the first vaccine dose
timeFrame: 60 days
measure: Prevention of COVID19
timeFrame: 365 days
measure: Prevention of severe COVID19
timeFrame: 365 days
measure: Immunogenicity and immunosuppression level
timeFrame: 365 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Study officials:
affiliation: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
name: Letizia Corinna Morlacchi, MD
role: PRINCIPAL_INVESTIGATOR
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