Clinical trial NCT05338736: Humoral and Cellular Immunity in First-cycle SARS-CoV-2 Vaccinated COVID-19 Patients
Official title: Differences in Humoral and Cellular Immunity in First-cycle Vaccinated Patients Infected by SARS-COV-2: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS CoV 2 Infection
COVID-19
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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)

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.


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

Primary outcomes:
measure: Differences between populations with respect to anti-SARS-CoV-2 immunoglobulins
timeFrame: At day 0
measure: Differences between populations with respect to cellular immunity
timeFrame: At day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: AOU Mater Domini
Study officials:
affiliation: Magna Graecia University
name: Federico Longhini, MD
role: PRINCIPAL_INVESTIGATOR
References: