Security Efficacy COVID-19 Vaccination (SECVAX)

Istituto Auxologico Italiano

Status: Completed

Conditions: SARS-CoV-2 Infection; Autoimmune State

Treatments: Diagnostic Test: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT05743361

20C121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 540 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

540 participants in 1 patient group

Autoantibodies

Description:

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

Treatment:

Diagnostic Test: Blood sampling