Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination (DANTE-SIRIO 7) Study

Conditions
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SARS-CoV2 Infection, SARS-CoV2 Antibodies

Intervention / Treatment
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* Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule
* Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent to study Age ≥ 18 years Receiving two doses of the BNT162b2 vaccine Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| participants willing to receive a 3-dose vaccination schedule<br>participants who received a 2-dose vaccination schedule, willing to receive a 3rd dose | Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule<br>* evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule willing to receive a 3rd dose of vaccine<br>|
| participants unwilling to receive a 3rd dose of vaccination<br>participants who received a 2-dose vaccination schedule, unwilling to receive a 3rd dose | Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule<br>* evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule unwilling to receive a 3rd dose of vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 0-12 months | 
| confirmed COVID-19 after vaccination | verification of COVID-19 based on survey filled by participants on each visit | 0-12 months |