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

University Magna Graecia

Status: Completed

Conditions: COVID-19; SARS CoV 2 Infection

Treatments: Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin); Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin); Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)

Study type: Observational

Funder types: Other

Identifiers

NCT05338736

Immune-COVID

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 3 patient groups

Control group

Description:

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.

Treatment:

Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)

Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)

Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin)

Asymptomatic group

Description:

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

Treatment:

Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)

Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)

Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin)

Symptomatic group

Description:

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

Treatment:

Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)

Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)

Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin)