- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04733807
Antibodies Response to mRNA Vaccine Against Covid-19 (SCAREAID)
Sars-Cov2 Antibodies Response to vaccinE Against covId-19 Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lugi Iuliano, M.D.
- Phone Number: +393406462332
- Email: luigi.iuliano@uniroma1.it
Study Contact Backup
- Name: Alessandro Polidoro, M.D.
- Phone Number: +393478115718
- Email: alessandro.polidoro@uniroma1.it
Study Locations
-
-
LT
-
Latina, LT, Italy, 04100
- Recruiting
- ICOT-Sapienza University Hospital
-
Contact:
- Lugi Iuliano, M.D.
- Phone Number: +393406462332
- Email: luigi.iuliano@uniroma1.it
-
Contact:
- Alessandro Polidoro, M.D.
- Phone Number: +393478115718
- Email: alessandro.polidoro@uniroma1.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Hospital employers vaccinated against Sars-Cov2
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum IgG antibodies levels in response to vaccine
Time Frame: Serum antibody at 1 month
|
Determination of IgG levels in serum
|
Serum antibody at 1 month
|
Serum IgG antibodies levels in response to vaccine
Time Frame: Serum antibody at 3 months
|
Determination of IgG levels in serum
|
Serum antibody at 3 months
|
Serum IgG antibodies levels in response to vaccine
Time Frame: Serum antibody at 6 months
|
Determination of IgG levels in serum
|
Serum antibody at 6 months
|
Serum IgG antibodies levels in response to vaccine
Time Frame: Serum antibody at 12 months
|
Determination of IgG levels in serum
|
Serum antibody at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 12 months
|
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
|
Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCAREAID
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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