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

NCT05338736 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2022-07-19

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • University Magna Graecia

    lead OTHER

Principal Investigators

  • Federico Longhini, MD · Magna Graecia University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-05-27
Completion
2022-05-27

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05338736 on ClinicalTrials.gov