NCT05338736

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

Completed Last updated 19 July 2022

What this trial tests

trial testing LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin) in SARS CoV 2 Infection in 45 participants. Completed in 27 May 2022.

Timeline

1 April 2022

Primary endpoint
27 May 2022

27 May 2022

Quick facts

Lead sponsor	University Magna Graecia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	45
Start date	1 April 2022
Primary completion	27 May 2022
Estimated completion	27 May 2022
Sites	1 location across Italy

Drugs / interventions tested

• LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)
• LIAISON SARS-CoV2-IgM (DiaSorin)
• Human IFN-g ELISpot PLUS (ALP) (AUROGENE)

Conditions studied

• SARS CoV 2 Infection — all drugs for SARS CoV 2 Infection →
• COVID-19 — all drugs for COVID-19 →

Sponsor

University Magna Graecia

Who can join

18 and older, any sex, with SARS CoV 2 Infection or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Severe and mild-moderate SARS-CoV-2 vaccinated patients show different frequencies of IFNγ-releasing cells: An exploratory study.
   Garofalo E, Biamonte F, Palmieri C, Battaglia AM, et al · · 2023 · cited 7× · PMID 36757971 · DOI 10.1371/journal.pone.0281444