SARS-CoV2 InfectionDANTE-SIRIO 7NCT05109585
Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study
An observational study of SARS-CoV2 Infection and SARS-CoV2 Antibodies, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
Trial summary
Great expectations to control the pandemic are placed in vaccines against COVID-19. Currently, the four COVID-19 vaccines approved in the European Union. We have designed the study assessing the anti-SARS-CoV-2 IgG antibody titer after vaccination cycle the BNT162b2 vaccine in several time points relating these… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection, SARS-CoV2 Antibodies
- What is being tested?
- assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule and assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule
- Type of treatment
- Vaccines
- How many people
- 1,000 participants
- Where
- 1 sitePoland
- Study dates
- 20 Apr 2021to 31 Dec 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: The study includes healthy, unselected volunteers from the staff of Antoni Jurasz University Hospital No.1 in Bydgoszczand students of Collegium Medicum, Nicolaus Copernicus University. Approximately1000 adult participants are planned to be included in the study
Who may be able to join
- Provision of informed consent to study
- Age ≥ 18 years
- Receiving two doses of the BNT162b2 vaccine
Who cannot join
- patients who did not complete 2-dose vaccination schedule
- patients who received any other vaccine than BNT162b2
- patients considered by investigator to be unable to cooperate
Trial locations and contacts
1 site in 1 country.
Poland1 site
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094
About this study
Official title: Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination (DANTE-SIRIO 7) Study
Great expectations to control the pandemic are placed in vaccines against COVID-19. Currently, the four COVID-19 vaccines approved in the European Union. We have designed the study assessing the anti-SARS-CoV-2 IgG antibody titer after vaccination cycle the BNT162b2 vaccine in several time points relating these results to the COVID-19 history and severity of symptoms during the disease and after the first and second vaccine dose
Read the detailed description
The study includes healthy, unselected volunteers from the staff of Antoni Jurasz University Hospital No.1 in Bydgoszcz and students of Collegium Medicum, Nicolaus Copernicus University. To meet the inclusion criteria patients will have to be vaccinated with two doses of the BNT162b2 vaccine. The assessment of the anti-SARS-CoV-2 IgG antibody titer at several time points in each participant. Fresh serum samples were used to measure SARS-CoV-2 IgG on the Siemens Atellica system (Siemens Healthineers, Erlangen, Germany). Results of SARS-CoV-2 IgG were given as U/ml, whereby the cut-off for positivity was defined as ≥1.0 U/ml.
- Conditions
- SARS-CoV2 Infection, SARS-CoV2 Antibodies
- Being tested
- assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule, assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose scheduleDiagnostic test
evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule willing to receive a 3rd dose of vaccine
assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose scheduleDiagnostic test
evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule unwilling to receive a 3rd dose of vaccine
| Study group | Role | What they receive |
|---|---|---|
| participants willing to receive a 3-dose vaccination schedule | participants who received a 2-dose vaccination schedule, willing to receive a 3rd dose Receives: Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule | |
| participants unwilling to receive a 3rd dose of vaccination | participants who received a 2-dose vaccination schedule, unwilling to receive a 3rd dose Receives: Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
the anti-SARS-CoV-2 IgG antibody concentration 3 months after vaccination cycle with the BNT162b2 vaccine
evaluation of anti-SARS-CoV-2 IgG antibody concentration 3 months after 2-dose vaccination with BNT162b2 vaccine
Measured: 0-12 months
Secondary outcomes (4)
the anti-SARS-CoV-2 IgG antibody concentration 6, 9 and 12 months after two-dose vaccination cycle
evaluation of anti-SARS-CoV-2 IgG antibody concentration at particular time points in 2-dose vaccination schedule
Measured: 0-12 months
the anti-SARS-CoV-2 IgG antibody concentration immediately before, 1 and 3 months after the third vaccine dose
evaluation of anti-SARS-CoV-2 IgG antibody concentration at particular time points after 3rd dose of vaccine
Measured: 0-12 months
local and/or systemic adverse reactions after vaccination
verification of any adverse events occurrence based on survey filled by participants on each visit
Measured: 0-12 months
confirmed COVID-19 after vaccination
verification of COVID-19 based on survey filled by participants on each visit
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start20 Apr 2021
- Primary completion12 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacek Kubica, Collegium Medicum w Bydgoszczy
- Investigators
- Jacek Kubica, Prof., Principal investigator, Collegium Medicum w Bydgoszczy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109585
- Sponsor's protocol ID
- DANTE- SIRIO 7
- Acronym
- DANTE-SIRIO 7
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 5 Nov 2021
- 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 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination (DANTE-SIRIO 7) Study
- ClinicalTrials.gov ID
- NCT05109585
- Acronym / sponsor ID
- DANTE-SIRIO 7 / DANTE- SIRIO 7
- Conditions
- SARS-CoV2 Infection, SARS-CoV2 Antibodies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 12 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Nov 2021 (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.
Great expectations to control the pandemic are placed in vaccines against COVID-19. Currently, the four COVID-19 vaccines approved in the European Union. We have designed the study assessing the anti-SARS-CoV-2 IgG antibody titer after vaccination cycle the BNT162b2 vaccine in several time points relating these results to the COVID-19 history and severity of symptoms during the disease and after the first and second vaccine dose
Detailed description
The study includes healthy, unselected volunteers from the staff of Antoni Jurasz University Hospital No.1 in Bydgoszcz and students of Collegium Medicum, Nicolaus Copernicus University. To meet the inclusion criteria patients will have to be vaccinated with two doses of the BNT162b2 vaccine. The assessment of the anti-SARS-CoV-2 IgG antibody titer at several time points in each participant. Fresh serum samples were used to measure SARS-CoV-2 IgG on the Siemens Atellica system (Siemens Healthineers, Erlangen, Germany). Results of SARS-CoV-2 IgG were given as U/ml, whereby the cut-off for positivity was defined as ≥1.0 U/ml.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| participants willing to receive a 3-dose vaccination schedule | – | Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose scheduleparticipants who received a 2-dose vaccination schedule, willing to receive a 3rd dose |
| participants unwilling to receive a 3rd dose of vaccination | – | Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose scheduleparticipants who received a 2-dose vaccination schedule, unwilling to receive a 3rd dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes healthy, unselected volunteers from the staff of Antoni Jurasz University Hospital No.1 in Bydgoszczand students of Collegium Medicum, Nicolaus Copernicus University. Approximately1000 adult participants are planned to be included in the study
Key inclusion criteria (3 listed)
- Provision of informed consent to study
- Age ≥ 18 years
- Receiving two doses of the BNT162b2 vaccine
Key exclusion criteria (3 listed)
- patients who did not complete 2-dose vaccination schedule
- patients who received any other vaccine than BNT162b2
- patients considered by investigator to be unable to cooperate
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 |
|---|---|---|
| assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose scheduleevaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule willing to receive a 3rd dose of vaccine | Diagnostic test | participants willing to receive a 3-dose vaccination schedule |
| assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose scheduleevaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule unwilling to receive a 3rd dose of vaccine | Diagnostic test | participants unwilling to receive a 3rd dose of vaccination |
Primary outcome
the anti-SARS-CoV-2 IgG antibody concentration 3 months after vaccination cycle with the BNT162b2 vaccine
Time frame: 0-12 months
evaluation of anti-SARS-CoV-2 IgG antibody concentration 3 months after 2-dose vaccination with BNT162b2 vaccine
4 secondary outcomes
the anti-SARS-CoV-2 IgG antibody concentration 6, 9 and 12 months after two-dose vaccination cycle
Time frame: 0-12 months
the anti-SARS-CoV-2 IgG antibody concentration immediately before, 1 and 3 months after the third vaccine dose
Time frame: 0-12 months
local and/or systemic adverse reactions after vaccination
Time frame: 0-12 months
confirmed COVID-19 after vaccination
Time frame: 0-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- 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.
Jacek Kubica, Prof. principal investigator
Collegium Medicum w Bydgoszczy
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 SARS-CoV2 Infection and SARS-CoV2 Antibodies, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Nov 2021. 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 Poland. 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?
Results are not available in the source record.
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?
the anti-SARS-CoV-2 IgG antibody concentration 3 months after vaccination cycle with the BNT162b2 vaccine (time frame: 0-12 months). 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 5 Nov 2021.