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Immune-Mediated Mechanisms in Patients Testing Positive for SARS-CoV-2: Protocol for a Multianalysis Study
Giuseppe Ietto1, Lorenzo Mortara2, Daniela Dalla Gasperina3
1General Emergency and Transplant Surgery Department, University of Insubria, Varese, Italy.
JMIR Research Protocols
|December 2, 2021
Summary
Vaccination may offer protection against severe COVID-19 by stimulating immune responses, potentially through trained immunity. This study investigates immune cell activity in relation to vaccination history and severe SARS-CoV-2 infection.
Area of Science:
- Immunology
- Virology
- Epidemiology
Background:
- The novel coronavirus (SARS-CoV-2) presents a high mortality rate, particularly in individuals over 50.
- Factors beyond comorbidities may influence SARS-CoV-2 response, with vaccination hypothesized to provide broader immune stimulation.
- Concepts like the 'bystander effect' and 'trained immunity' suggest vaccination can confer cross-protection against various antigens.
Purpose of the Study:
- To investigate immune cell hyperactivity (monocytes, NK cells) and dysfunction (T cells) in severe SARS-CoV-2 infection.
- To correlate clinical data and vaccination history with immune patterns to identify protective factors.
- To characterize immune cell phenotypes and activation states in healthy individuals post-Pfizer vaccination.
Main Methods:
- Experimental analysis of innate immune response and genetic profiles.
- Epidemiological analysis of patient vaccination histories.
- Clinical analysis to determine immunological profiles.
Main Results:
- Study protocol approved and initiated in April 2020.
- Enrollment completed by February 2021.
- Ongoing immunological analysis with expected completion by December 2022.
Conclusions:
- Identification of distinct patient populations with specific immunological patterns (cytokines, immune cell activity).
- Anamnestic data (vaccinations, comorbidities) and immunological findings can define severe COVID-19 risk profiles.
- Understanding these immunological phenomena may lead to novel immunomodulatory treatments for COVID-19.

