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OpenTrials
Completed

NCT Number: NCT05338736

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Mater Domini

Catanzaro, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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)

Primary outcomes

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

    Time frame: 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

  2. Differences between populations with respect to cellular immunity

    Time frame: At day 0

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

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2022
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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