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OpenTrials
Completed

NCT Number: NCT05116748

COVID19 Vaccine in SOT 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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Liver Transplant; Complications Lung Diseases Lung Transplant; Complications Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccination Vaccine Adverse Reaction Vaccine Reaction Vaccine Response Impaired Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID19 mRNA vaccine

Biological

Administration of COVID19 mRNA vaccine

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. Immunogenicity and immunosuppression level

    Time frame: 365 days

    To compare the obtained (both antibody and T cell mediated) immunogenicity with the immunosuppression levels

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

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

Acronym: COVID19_VaxSOT

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Nov 11, 2021
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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