Security Efficacy COVID-19 Vaccination

Istituto Auxologico Italiano540 enrolled

Overview

Preliminary data support a possible molecular mimicry between SARS-CoV-2 and autologous components. This suggests the occurrence of autoimmunity during COVID-19. Consistently, autoimmunity may occur after SARS-CoV2 vaccination. The study aims to investigate the production of autoantibodies after vaccination in healtcare workers.

Healtcare workers undergoing SARS-CoV-2 vaccination (with RNA-vaccines) will be included on a voluntary basis. Blood samples will be collected before and after vaccination (1 -3 - 6 - 12 months). All the vaccination side effects will be registered.

Study Type

OBSERVATIONAL

Enrollment

540

Conditions

Autoimmune State SARS-CoV-2 Infection

Interventions

Blood samplingDIAGNOSTIC_TEST

Detection of ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthcare workers undergoing SARS-CoV-2 vaccination Exclusion Criteria: * Pregnancy * Full blown autoimmune diseases * Active vaccinations within 3 months before enrolment (excluding the influenza vaccine) * Previous vaccination severe side effects

Locations (1)

Istituto Auxologico Italiano IRCCS

Milan, Italy

Outcomes

Primary Outcomes

Change in Autoantibody Levels

ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti-TPO, anti-TG

Time frame: Before vaccination and 1, 6 and 12 months after vaccination

Data from ClinicalTrials.gov

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