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Security Efficacy COVID-19 Vaccination (SECVAX)

I

Istituto Auxologico Italiano

Status

Completed

Conditions

SARS-CoV-2 Infection
Autoimmune State

Treatments

Diagnostic Test: Blood sampling

Study type

Observational

Funder types

Other

Identifiers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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