Covid-19
Conditions
Keywords
vaccine, Covid-19, safety, Sars-Cov2
Brief 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.
Detailed 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.
Interventions
BIOLOGICALBNT162b2 mRNA Covid-19 Vaccine
Hospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response.
Sponsors
ICOT University Hospital
University of Roma La Sapienza
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Hospital employers vaccinated against Sars-Cov2
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum IgG antibodies levels in response to vaccine | Serum antibody at 1 month | Determination of IgG levels in serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sars-Cov2 infection in vaccinated subjects | up to 12 months | Monitoring of Sars-Cov2 infection by a nasopharyngeal swab of spike protein Ag, and PCR confirmation in case of Ag swab positivity. |
| Covid-19 disease in vaccinated subjects | Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year. | Monitoring the occurrence of Covid-19 disease in vaccinated people |
Countries
Italy
Contacts
Primary ContactLugi Iuliano, M.D.
Backup ContactAlessandro Polidoro, M.D.
Outcome results
None listed