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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT04733807
Study type Observational
Source University of Roma La Sapienza
Contact Lugi Iuliano, M.D.
Phone +393406462332
Email luigi.iuliano@uniroma1.it
Status Recruiting
Phase
Start date January 28, 2021
Completion date February 1, 2022

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