NCT05338736

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: University Magna Graecia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• SARS CoV 2 Infection
• COVID-19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)	Kit to test the concentration of Immunoglobulin G anti-SARS-CoV-2 in the plasma of included patients
DIAGNOSTIC_TEST	LIAISON SARS-CoV2-IgM (DiaSorin)	Kit to test the concentration of Immunoglobulin M anti-SARS-CoV-2 in the plasma of included patients
DIAGNOSTIC_TEST	Human IFN-g ELISpot PLUS (ALP) (AUROGENE)	Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs)

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-05-27
• Completion: 2022-05-27
• First posted: 2022-04-21
• Last updated: 2022-07-19

Locations

1 site across 1 country: Italy