Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733807
Status:
UNKNOWN
Last Update Posted:
2021-05-11
First Post:
2021-01-28
Brief Title:
Antibodies Response to mRNA Vaccine Against Covid-19
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Sars-Cov2 Antibodies Response to vaccinE Against covId-19 Disease
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCAREAID
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 reactionsevents
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 reactionsevents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None