SECVAX: Security Efficacy COVID-19 Vaccination

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Completed

CT.gov ID

NCT05743361

Collaborator

(none)

540

Enrollment

Location

15.7

Actual Duration (Months)

34.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune State SARS-CoV-2 Infection	Diagnostic Test: Blood sampling

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.

Study Design

Study Type:

Observational

Actual Enrollment :

540 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

Studio Sierologico in Volontari Vaccinati Contro COVID-19

Actual Study Start Date :

Jan 7, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Autoantibodies Detection of: ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG	Diagnostic Test: Blood sampling Detection of ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG

Arm

Intervention/Treatment

Autoantibodies

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

Diagnostic Test: Blood sampling

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Auxologico Italiano IRCCS	Milan		Italy	20145

Sponsors and Collaborators

Istituto Auxologico Italiano

Investigators

Principal Investigator: Pierluigi Meroni, MD, Istituto Auxologico Italiano IRCCS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Auxologico Italiano

ClinicalTrials.gov Identifier:

NCT05743361

Other Study ID Numbers:

20C121

First Posted:

Feb 24, 2023

Last Update Posted:

Feb 24, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Istituto Auxologico Italiano

SARS-CoV-2

Vaccine

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Feb 24, 2023