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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS CoV 2 Infection
• Intervention / Treatment: 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)

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy
    • AOU Mater Domini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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)
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); 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)
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); 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Magna Graecia

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2022
• Primary Completion (ACTUAL): May 27, 2022
• Study Completion (ACTUAL): May 27, 2022

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (ACTUAL): April 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Immune-COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual patients data will be shared only after the publication of the study on an international peer-reviewed journal and on scientific and intelligible proposal
• IPD Sharing Time Frame: Data will be available after publication on an indexed international and peer-reviewed journal
• IPD Sharing Access Criteria: Access will be allowed after contacting by email the principal investigator, by providing and intelligible and scientific proposal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No