Humoral and Cellular Immunity in First-cycle SARS-CoV-2 Vaccinated COVID-19 Patients

Study Overview
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Brief Summary
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Infection by the recent Coronavirus (SARS-CoV-2) has generated at a pandemic level a new pathology, called COVID-19, characterized by flu-like symptoms up to severe acute respiratory failure. The pathogenesis of the disease involves both humoral and cellular immunological responses; cell-mediated immunity is the first and most effective immune response to viral infection. To date, despite the extensive scientific research aimed at curing COVID-19, there are few effective means to tackle SARS-CoV-2 infection and reduce its disease progression. Among these, a first complete anti-SARS-CoV-2 vaccination course has been shown to significantly reduce the development of the disease towards the more severe forms requiring hospital and intensive care. On the other hand, over time the antibody response induced by vaccines against SARS-CoV-2 decreases, so much so as to indicate the need for a third booster dose. This translates into the fact that some patients who have undergone a complete first vaccination course, with third dose booster indications, develop severe critical disease, with the need for hospitalization. On the other hand, other patients with the same vaccination status do not develop the disease, although they are also positive for SARS-CoV-2. The investigators therefore hypothesized that the humoral and cell-mediated response among groups of patients may be radically different. For these reasons, the investigators designed this observational pilot study in order to analyze humoral and cell-mediated responses in SARS-CoV-2 positive first complete vaccination patients.

Official Title
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Differences in Humoral and Cellular Immunity in First-cycle Vaccinated Patients Infected by SARS-COV-2: an Observational Study

Conditions
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SARS CoV 2 Infection, COVID-19

Intervention / Treatment
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* Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)
* Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin)
* Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a complete first-cycle vaccination against SARS-CoV-2 performed 4 to 7 months before. Exclusion Criteria: Presence of malignancy under chemotherapy Patient with previous transplantation Patient receiving immuno-modulatory or immunosuppressive drugs Patient receiving corticosteroid therapy since more than 10 days Pregnancy Consent withdrawal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Control patients with a complete first-cycle vaccination against SARS-CoV-2, received between 4 to 7 months before the inclusion, and with a nasopharyngeal swab negative for SARS-CoV-2 isolation. | Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)<br>* Kit to test the concentration of Immunoglobulin G anti-SARS-CoV-2 in the plasma of included patients<br>Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin)<br>* Kit to test the concentration of Immunoglobulin M anti-SARS-CoV-2 in the plasma of included patients<br>Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)<br>* Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs)<br>|
| Asymptomatic group<br>Patients with a complete first-cycle vaccination against SARS-CoV-2, received between 4 to 7 months before the inclusion, with a nasopharyngeal swab positive for SARS-CoV-2 isolation, in absence of any symptoms of COVID-19 | Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)<br>* Kit to test the concentration of Immunoglobulin G anti-SARS-CoV-2 in the plasma of included patients<br>Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin)<br>* Kit to test the concentration of Immunoglobulin M anti-SARS-CoV-2 in the plasma of included patients<br>Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)<br>* Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs)<br>|
| Symptomatic group<br>Patients with a complete first-cycle vaccination against SARS-CoV-2, received between 4 to 7 months before the inclusion, with a nasopharyngeal swab positive for SARS-CoV-2 isolation, with moderate to severe symptoms of COVID-19 | Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)<br>* Kit to test the concentration of Immunoglobulin G anti-SARS-CoV-2 in the plasma of included patients<br>Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin)<br>* Kit to test the concentration of Immunoglobulin M anti-SARS-CoV-2 in the plasma of included patients<br>Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)<br>* Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between populations with respect to anti-SARS-CoV-2 immunoglobulins | After obtaining plasma of included patients, the plasma will be processed with a dedicated kit to measure the concentration of Immunoglobulin G and M. Differences between patients' cohorts will be assessed | At day 0 | 
| Differences between populations with respect to cellular immunity | Mononuclear immunity cells will be analyzed with a dedicated ELISpot kit to assess their response to SARS-CoV-2 | At day 0 |