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

COVID-19 Clinical Trial

Official title:

Differences in Humoral and Cellular Immunity in First-cycle Vaccinated Patients Infected by SARS-COV-2: an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338736
• Other study ID #: Immune-COVID
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: May 27, 2022

Study information

• Verified date: July 2022
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 27, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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
• LIAISON SARS-CoV2-IgM (DiaSorin)
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)
Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs)

Locations

Country	Name	City	State
Italy	AOU Mater Domini	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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