Autoimmune StateSECVAXNCT05743361
Security Efficacy COVID-19 Vaccination
An observational study of Autoimmune State and SARS-CoV-2 Infection, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autoimmune State, SARS-CoV-2 Infection
- What is being tested?
- Blood sampling
- How many people
- 540 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2021to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare workers undergoing SARS-CoV-2 vaccination
Who may be able to join
- Healthcare workers undergoing SARS-CoV-2 vaccination
Who cannot join
- Pregnancy
- Full blown autoimmune diseases
- Active vaccinations within 3 months before enrolment (excluding the influenza vaccine)
- Previous vaccination severe side effects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studio Sierologico in Volontari Vaccinati Contro COVID-19
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.
Read the 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.
- Conditions
- Autoimmune State, SARS-CoV-2 Infection
- Being tested
- Blood sampling
- Keywords
- SARS-CoV-2, Vaccine
- Medical subject headings
- Autoimmune Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDiagnostic test
Detection of ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG
| Study group | Role | What they receive |
|---|---|---|
| Autoantibodies | Detection of: ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG Receives: Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Autoantibody Levels
ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti-TPO, anti-TG
Measured: Before vaccination and 1, 6 and 12 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start7 Jan 2021
- Primary completion31 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierluigi Meroni, MD, Principal investigator, Istituto Auxologico Italiano IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743361
- Sponsor's protocol ID
- 20C121
- Acronym
- SECVAX
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Sierologico in Volontari Vaccinati Contro COVID-19
- ClinicalTrials.gov ID
- NCT05743361
- Acronym / sponsor ID
- SECVAX / 20C121
- Conditions
- Autoimmune State, SARS-CoV-2 Infection
- Keywords
- SARS-CoV-2, Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autoantibodies | – | Diagnostic Test: Blood samplingDetection of: ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers undergoing SARS-CoV-2 vaccination
Key inclusion criteria (1 listed)
- Healthcare workers undergoing SARS-CoV-2 vaccination
Key exclusion criteria (4 listed)
- Pregnancy
- Full blown autoimmune diseases
- Active vaccinations within 3 months before enrolment (excluding the influenza vaccine)
- Previous vaccination severe side effects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingDetection of ANA, AMA, anti-dsDNA, anti-ENA, anti-MPO, anti-PR3, aPL, RF, ACPA, anti- TPO, anti-TG | Diagnostic test | Autoantibodies |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierluigi Meroni, MD principal investigator
Istituto Auxologico Italiano IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune State and SARS-CoV-2 Infection, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Autoantibody Levels (time frame: Before vaccination and 1, 6 and 12 months after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.