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NCT05743361 Clinical Trial

Security Efficacy COVID-19 Vaccination

SARS-CoV-2 Infection Clinical Trial

— SECVAX  

Official title:
Studio Sierologico in Volontari Vaccinati Contro COVID-19

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05743361
Other study ID # 20C121
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 7, 2021
Est. completion date April 30, 2022

Study information
Verified date February 2023
Source Istituto Auxologico Italiano
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 540
Est. completion date April 30, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood sampling
Detection of ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG

Locations
Country Name City State
Italy Istituto Auxologico Italiano IRCCS Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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