NCT05743361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 21, 2023

Last Update Submit

February 23, 2023

Conditions

Autoimmune StateSARS-CoV-2 Infection

Keywords

SARS-CoV-2Vaccine

Outcome Measures

Primary Outcomes (1)

  • Change in Autoantibody Levels

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

    Before vaccination and 1, 6 and 12 months after vaccination

Study Arms (1)

Autoantibodies

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

Diagnostic Test: Blood sampling

Interventions

Blood samplingDIAGNOSTIC_TEST

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

Autoantibodies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthcare workers undergoing SARS-CoV-2 vaccination

You may qualify if:

  • Healthcare workers undergoing SARS-CoV-2 vaccination

You may not qualify if:

  • Pregnancy
  • Full blown autoimmune diseases
  • Active vaccinations within 3 months before enrolment (excluding the influenza vaccine)
  • Previous vaccination severe side effects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

Location

MeSH Terms

Conditions

Autoimmune DiseasesCOVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pierluigi Meroni, MD

    Istituto Auxologico Italiano IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

February 24, 2023

Study Start

January 7, 2021

Primary Completion

December 31, 2021

Study Completion

April 30, 2022

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)