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In order to prevent reinfection, it is needed to detect the cellular-mediated immune response to the Sars-CoV-2 infection. The first goal of this study will be to detect the cellular-mediated immune response in patients affected by COVID-19 (with or without vaccination) and healthy subjects who undergone vaccination program. The second goal of this study will be to identify the genetic and epigenetic biomarkers that influence individual immunological response and clinical evolution to the severe manifestations of the COVID-19.
First goal: Characterization of the immune response using detailed phenotypic evaluation of the adaptive compartment comprising B, T, and NK cells. The Investigators aim is to detect the cellular-mediated immune response in patients affected by COVID-19 and subjects who undergone vaccination program.
The Investigators will recruit three classes of subjects:
Second goal: Evaluation of genetic and epigenetic biomarkers that influence individual immunological response and susceptibility to thromboembolic manifestations in severe COVID-19 hospitalized patients.
The Investigators will recruit:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe COVID-19 hospitalized patients | A total of 50 severe COVID-19 patients admitted to the Sub-Intensive Care Unit of A.O.R.N. Ospedali dei Colli, Cotugno Hospital, Naples (Italy) will be recruited, of which N=50 with thromboembolic complications (PE+) and N=50 without thromboembolic complications (PE-) balanced for age and sex of individuals. |
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| Healthy controls (comparator group) | As control group (CTRL), we will recruit a total of N=50 healthy subjects (never diagnosed with Sars-Cov2 infection) among the volunteer blood donors attending the U.O.C. Divisione di Immunologia Clinica, Immunoematologia, Medicina Trasfusionale e Immunologia dei Trapianti, Dipartimento di Medicina Interna e Specialistica, AOU, "L. Vanvitelli" University of Campania (Naples, Italy). |
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| COVID-19 patients compared with vaccinated subjects |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multitest 6 color TBNK and BD Lyotubes | Diagnostic Test | The Multitest 6 color TBNK allows us to count the population-specific B, T, NK cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Cellular-Mediated Immune Response | The Investigators will perform the BD Multitest 6-color TBNK by using 50 uL of peripheral blood to detect the absolute number (N) of CD3+, CD19+, CD16+, CD46+, CD4+ and CD8+ cells. | 3 Months |
| Detection of Cellular-Mediated Immune Response | The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the absolute number (N) of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of T cell subpopulation maturation | The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the absolute number (N) of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory. | 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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Cases:
Patients with previous diagnosed Sars-CoV-2 infection who did undergo vaccination.
Patients with previous diagnosed Sars-CoV-2 infection who did not undergo vaccination.
Subjects without diagnosed Sars-CoV-2 infection who adhered to vaccination program.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuditta Benincasa, BiolD. MSc | Contact | +39 0815667916 | giuditta.benincasa@unicampania.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O.C. Division of Clinical Immunology, Immunohematology, Transfusion Medicine and Transplant Immunology, Regional Reference Laboratory of Transplant Immunology, Department of Internal and Specialty Medicine, A.O.U., UniversityofCampania "Luigi Vanvitelli | Recruiting | Naples |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Peripheral blood, genomic DNA, RNA, and proteins.
| genomicDNA extraction | Biological | Peripheral blood biospecimens (about 10-15 mL) will be collected through venipuncture in EDTA tubes. Peripheral blood mononuclear cells (PBMCs) will be isolated using Ficoll® Paque Plus (Sigma-Aldrich) centrifugation gradient and genomic DNA will be extracted from fresh PBMCs using DNeasy Blood & Tissue kit (QIAGEN), according to manufacturer protocols |
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| Detection of T cell subpopulation maturation |
The Investigators will perform the BD™ Lyotubes kit by using 150 uL of peripheral blood to detect the % of CD4+ and CD8+ cells undergoing to differentiation from naive T cells to central memory, effector memory, and terminal memory. |
| 5 months |
| 80138 |
| Italy |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |