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

Completed

• Conditions: SARS CoV 2 Infection; COVID-19
• Interventions: Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin); Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin); Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)

• Registration Number: NCT05338736
• Lead Sponsor: University Magna Graecia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-21
• Primary Completion: 2022-05-27
• Study Completion: 2022-05-27
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	LIAISON SARS-CoV2-IgM (DiaSorin)	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	LIAISON SARS-CoV2-IgM (DiaSorin)	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
Control group	LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)	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.
Symptomatic group	LIAISON SARS-CoV2-IgM (DiaSorin)	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
Asymptomatic group	LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)	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
Asymptomatic group	Human IFN-g ELISpot PLUS (ALP) (AUROGENE)	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
Control group	Human IFN-g ELISpot PLUS (ALP) (AUROGENE)	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.
Symptomatic group	LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)	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
Symptomatic group	Human IFN-g ELISpot PLUS (ALP) (AUROGENE)	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

Primary Outcome Measures

Name	Time	Method
Differences between populations with respect to anti-SARS-CoV-2 immunoglobulins	At day 0	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
Differences between populations with respect to cellular immunity	At day 0	Mononuclear immunity cells will be analyzed with a dedicated ELISpot kit to assess their response to SARS-CoV-2

Trial Locations

Locations (1)

AOU Mater Domini; 🇮🇹 Catanzaro, Italy