Antibodies Response to mRNA Vaccine Against Covid-19 (SCAREAID)
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|ClinicalTrials.gov Identifier: NCT04733807|
Recruitment Status : Recruiting
First Posted : February 2, 2021
Last Update Posted : May 11, 2021
|Condition or disease||Intervention/treatment|
|Covid-19||Biological: BNT162b2 mRNA Covid-19 Vaccine|
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|
|Estimated Enrollment :||600 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Sars-Cov2 Antibodies Response to vaccinE Against covId-19 Disease|
|Actual Study Start Date :||January 28, 2021|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||February 1, 2022|
- Biological: BNT162b2 mRNA Covid-19 Vaccine
Hospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response.
- Serum IgG antibodies levels in response to vaccine [ Time Frame: Serum antibody at 1 month ]Determination of IgG levels in serum
- Serum IgG antibodies levels in response to vaccine [ Time Frame: Serum antibody at 3 months ]Determination of IgG levels in serum
- Serum IgG antibodies levels in response to vaccine [ Time Frame: Serum antibody at 6 months ]Determination of IgG levels in serum
- Serum IgG antibodies levels in response to vaccine [ Time Frame: Serum antibody at 12 months ]Determination of IgG levels in serum
- Sars-Cov2 infection in vaccinated subjects [ Time Frame: 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 [ Time Frame: Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year. ]Monitoring the occurrence of Covid-19 disease in vaccinated people
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04733807
|Contact: Lugi Iuliano, M.D.||+email@example.com|
|Contact: Alessandro Polidoro, M.D.||+firstname.lastname@example.org|
|Principal Investigator:||Luigi Iuliano, M.D.||Sapienza University of Rome|