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

NCT ID: NCT05338736

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-05-27

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.

Detailed Description

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Conditions

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SARS CoV 2 Infection COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)

Intervention Type DIAGNOSTIC_TEST

Kit to test the concentration of Immunoglobulin G anti-SARS-CoV-2 in the plasma of included patients

LIAISON SARS-CoV2-IgM (DiaSorin)

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs)

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

LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)

Intervention Type DIAGNOSTIC_TEST

Kit to test the concentration of Immunoglobulin G anti-SARS-CoV-2 in the plasma of included patients

LIAISON SARS-CoV2-IgM (DiaSorin)

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs)

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

LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)

Intervention Type DIAGNOSTIC_TEST

Kit to test the concentration of Immunoglobulin G anti-SARS-CoV-2 in the plasma of included patients

LIAISON SARS-CoV2-IgM (DiaSorin)

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs)

Interventions

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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

Intervention Type 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

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Magna Graecia

OTHER

Sponsor Role lead

Responsible Party

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Federico Longhini

Director of the Intensive Care and Anesthesia Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Federico Longhini, MD

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University

Locations

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AOU Mater Domini

Catanzaro, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Immune-COVID

Identifier Type: -

Identifier Source: org_study_id

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