Security Efficacy COVID-19 Vaccination

NCT ID: NCT05743361

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-07

Study Completion Date

2022-04-30

Brief Summary

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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

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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.

Conditions

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Autoimmune State SARS-CoV-2 Infection

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Autoantibodies

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

Blood sampling

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Blood sampling

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierluigi Meroni, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano IRCCS

Locations

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Istituto Auxologico Italiano IRCCS

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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20C121

Identifier Type: -

Identifier Source: org_study_id

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