Security Efficacy COVID-19 Vaccination | NCT05743361

Studies
Security Efficacy COVID-19 Vaccination

NCT05743361

Sponsor

Istituto Auxologico Italiano

Status

Completed

Last Update Posted

Feb 24, 2023Actual

Enrollment

540Actual

Phase

Not provided

Conditions

Autoimmune State
SARS-CoV-2 Infection

Interventions

Blood sampling

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Feb 21, 2023

First Submission Date that Met QC Criteria

Feb 23, 2023

First Posted Date

Feb 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2023

Last Update Posted Date

Feb 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

540Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Blood sampling	Diagnostic Test	Detection of ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG	Autoantibodies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthcare workers undergoing SARS-CoV-2 vaccination

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierluigi Meroni, MD	Istituto Auxologico Italiano IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Auxologico Italiano IRCCS		Milan		20145	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001327	Autoimmune Diseases
D000086382	COVID-19

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided