Security Efficacy COVID-19 Vaccination
- Conditions
- Autoimmune StateSARS-CoV-2 Infection
- Interventions
- Diagnostic Test: Blood sampling
- Registration Number
- NCT05743361
- Lead Sponsor
- Istituto Auxologico Italiano
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 540
- Healthcare workers undergoing SARS-CoV-2 vaccination
- Pregnancy
- Full blown autoimmune diseases
- Active vaccinations within 3 months before enrolment (excluding the influenza vaccine)
- Previous vaccination severe side effects
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Autoantibodies Blood sampling Detection of: ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG
- Primary Outcome Measures
Name Time Method Change in Autoantibody Levels Before vaccination and 1, 6 and 12 months after vaccination ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti-TPO, anti-TG
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Istituto Auxologico Italiano IRCCS
🇮🇹Milan, Italy