Skip to main content
Clinical Trials/NCT05338736
NCT05338736
Completed
Not Applicable

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

University Magna Graecia1 site in 1 country45 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SARS CoV 2 Infection
Sponsor
University Magna Graecia
Enrollment
45
Locations
1
Primary Endpoint
Differences between populations with respect to anti-SARS-CoV-2 immunoglobulins
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
May 27, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Magna Graecia
Responsible Party
Principal Investigator
Principal Investigator

Federico Longhini

Director of the Intensive Care and Anesthesia Department

University Magna Graecia

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

Loading locations...

Similar Trials