Antibodies Response to mRNA Vaccine Against Covid-19

Study Overview
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Brief Summary
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Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers. The investigators undertake this study to monitor IgG evolution after vaccination in the participant hospital settings, which includes 500 subjects.

Detailed Description
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Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers. The investigators undertake this observational study to monitor antibody evolution after vaccination in a hospital setting. The primary endpoint is serum IgG at the first month of 2nd jab, and at 3, 6, and 12 months afterward. As secondary measures, nasopharyngeal swabs are included, at fortnight intervals to detects the spike protein antigen, in the event that putative vaccine inefficacy would expose the health personnel to Covid-19 disease with potential spreading to inpatients. Further, clinical signs and symptoms are monitored at the weekly interval in the context of adverse reactions/events.

Official Title
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Sars-Cov2 Antibodies Response to vaccinE Against covId-19 Disease

Conditions
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Covid-19

Intervention / Treatment
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* Biological: BNT162b2 mRNA Covid-19 Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospital employers vaccinated against Sars-Cov2 Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Biological: BNT162b2 mRNA Covid-19 Vaccine|Hospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum IgG antibodies levels in response to vaccine | Determination of IgG levels in serum | Serum antibody at 1 month | 
| Serum IgG antibodies levels in response to vaccine | Determination of IgG levels in serum | Serum antibody at 3 months | 
| Serum IgG antibodies levels in response to vaccine | Determination of IgG levels in serum | Serum antibody at 6 months | 
| Serum IgG antibodies levels in response to vaccine | Determination of IgG levels in serum | Serum antibody at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sars-Cov2 infection in vaccinated subjects | Monitoring of Sars-Cov2 infection by a nasopharyngeal swab of spike protein Ag, and PCR confirmation in case of Ag swab positivity. | up to 12 months | 
| Covid-19 disease in vaccinated subjects | Monitoring the occurrence of Covid-19 disease in vaccinated people | Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, Covid-19, safety, Sars-Cov2