Security Efficacy COVID-19 Vaccination

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.

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Key information

Conditions

Autoimmune State Autoimmune Diseases COVID-19 Coronaviridae Infections Coronavirus Infections Immune System Diseases Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sars-CoV-2 Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Diagnostic Test

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

Primary outcomes

Change in Autoantibody Levels

Time frame: 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

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

Studio Sierologico in Volontari Vaccinati Contro COVID-19

Acronym: SECVAX

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Feb 24, 2023
Registry last updated: Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed