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.
Study Type
OBSERVATIONAL
Enrollment
600
Hospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response.
ICOT-Sapienza University Hospital
Latina, LT, Italy
RECRUITINGSerum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Time frame: Serum antibody at 1 month
Serum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Time frame: Serum antibody at 3 months
Serum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Time frame: Serum antibody at 6 months
Serum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Time frame: Serum antibody at 12 months
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.
Time frame: up to 12 months
Covid-19 disease in vaccinated subjects
Monitoring the occurrence of Covid-19 disease in vaccinated people
Time frame: Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year.
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