Antibodies Response to mRNA Vaccine Against Covid-19 (SCAREAID)

May 7, 2021 updated by: Luigi Iuliano, University of Roma La Sapienza

Sars-Cov2 Antibodies Response to vaccinE Against covId-19 Disease

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.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Health care, administrative, and technical workers of ICOT-Sapienza University Hospital

Description

Inclusion Criteria:

  • Hospital employers vaccinated against Sars-Cov2

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Collaborators

ICOT University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2021

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

January 31, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCAREAID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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