Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | 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. |
| |
| Asymptomatic group | 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 |
| |
| Symptomatic group | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin) | Diagnostic Test | Kit to test the concentration of Immunoglobulin G anti-SARS-CoV-2 in the plasma of included patients |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Forty-five patients will be totally enrolled in the study. Three cohorts of patients will be considered.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Federico Longhini, MD | Magna Graecia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Mater Domini | Catanzaro | Italy |
The individual patients data will be shared only after the publication of the study on an international peer-reviewed journal and on scientific and intelligible proposal
Data will be available after publication on an indexed international and peer-reviewed journal
Access will be allowed after contacting by email the principal investigator, by providing and intelligible and scientific proposal
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Twenty milliliters of whole blood will be collected from every included patient. Two milliliters will be centrifuged to obtain plasma within a speed range of 1300-2000g, for 10min at 25 ° C. Eighteen milliliters will be subjected to Ficoll density gradient separation to isolate mononuclear cells (PBMCs).
| LIAISON SARS-CoV2-IgM (DiaSorin) | Diagnostic Test | Kit to test the concentration of Immunoglobulin M anti-SARS-CoV-2 in the plasma of included patients |
|
| Human IFN-g ELISpot PLUS (ALP) (AUROGENE) | Diagnostic Test | Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs) |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |