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

NCT05338736 | Completed

• 1 other identifier: Immune-COVID
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS CoV 2 Infection; COVID-19

Outcome Measures

Primary Outcomes (2)

• Differences between populations with respect to anti-SARS-CoV-2 immunoglobulins

  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

  At day 0

• Differences between populations with respect to cellular immunity

  Mononuclear immunity cells will be analyzed with a dedicated ELISpot kit to assess their response to SARS-CoV-2

  At day 0

Study Arms (3)

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.

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)

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

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)

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

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)

Interventions

LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin) DIAGNOSTIC_TEST

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

Asymptomatic group; Control group; Symptomatic group

LIAISON SARS-CoV2-IgM (DiaSorin) DIAGNOSTIC_TEST

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

Asymptomatic group; Control group; Symptomatic group

Human IFN-g ELISpot PLUS (ALP) (AUROGENE) DIAGNOSTIC_TEST

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

Asymptomatic group; Control group; Symptomatic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Forty-five patients will be totally enrolled in the study. Three cohorts of patients will be considered. 1. Control group: 15 vaccinated patients with a pharyngeal swab negative for SARS-CoV-2 isolation 2. Asymptomatic group: 15 vaccinated patients with a pharyngeal swab positive for SARS-CoV-2 isolation and absence of symptoms related to the infection 3. Symptomatic group: 15 vaccinated patients with a pharyngeal swab positive for SARS-CoV-2 isolation and presence of moderate to severe symptoms related to the infection (i.e. peripheral oxygen saturation lower than 94% in room air)

You may qualify if:

• Patients with a complete first-cycle vaccination against SARS-CoV-2 performed 4 to 7 months before.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

AOU Mater Domini

Catanzaro, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Twenty milliliters of whole blood will be collected from every included patient. Two milliliters will be centrifuged to obtain plasma within a speed range of 1300-2000g, for 10min at 25 ° C. Eighteen milliliters will be subjected to Ficoll density gradient separation to isolate mononuclear cells (PBMCs).

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Federico Longhini, MD

  Magna Graecia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Intensive Care and Anesthesia Department

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 21, 2022
• Study Start: April 1, 2022
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after publication on an indexed international and peer-reviewed journal
• Access Criteria: Access will be allowed after contacting by email the principal investigator, by providing and intelligible and scientific proposal

Locations

IT (1)