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Security Efficacy COVID-19 Vaccination

Studio Sierologico in Volontari Vaccinati Contro COVID-19

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05743361
Acronym
SECVAX
Enrollment
540
Registered
2023-02-24
Start date
2021-01-07
Completion date
2022-04-30
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune State, SARS-CoV-2 Infection

Keywords

SARS-CoV-2, Vaccine

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.

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.

Interventions

DIAGNOSTIC_TESTBlood sampling

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

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Autoantibody LevelsBefore vaccination and 1, 6 and 12 months after vaccinationANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti-TPO, anti-TG

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026