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| Name | Class |
|---|---|
| ICOT University Hospital | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b2 mRNA Covid-19 Vaccine | Biological | Hospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Health care, administrative, and technical workers of ICOT-Sapienza University Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lugi Iuliano, M.D. | Contact | +393406462332 | luigi.iuliano@uniroma1.it | |
| Alessandro Polidoro, M.D. | Contact | +393478115718 | alessandro.polidoro@uniroma1.it |
| Name | Affiliation | Role |
|---|---|---|
| Luigi Iuliano, M.D. | University of Roma La Sapienza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICOT-Sapienza University Hospital | Recruiting | Latina | LT | 04100 | Italy |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Monitoring the occurrence of Covid-19 disease in vaccinated people
| Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |