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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
Sponsor:
Collaborator:
ICOT University Hospital
Information provided by (Responsible Party):
Luigi Iuliano, University of Roma La Sapienza

Study Description
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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.

Condition or disease Intervention/treatment
Covid-19 Biological: BNT162b2 mRNA Covid-19 Vaccine

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 Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Biological: BNT162b2 mRNA Covid-19 Vaccine
    Hospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response.

Outcome Measures
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Primary Outcome Measures :
  1. Serum IgG antibodies levels in response to vaccine [ Time Frame: Serum antibody at 1 month ]
    Determination of IgG levels in serum

  2. Serum IgG antibodies levels in response to vaccine [ Time Frame: Serum antibody at 3 months ]
    Determination of IgG levels in serum

  3. Serum IgG antibodies levels in response to vaccine [ Time Frame: Serum antibody at 6 months ]
    Determination of IgG levels in serum

  4. Serum IgG antibodies levels in response to vaccine [ Time Frame: Serum antibody at 12 months ]
    Determination of IgG levels in serum


Secondary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Health care, administrative, and technical workers of ICOT-Sapienza University Hospital
Criteria

Inclusion Criteria:

  • Hospital employers vaccinated against Sars-Cov2

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Lugi Iuliano, M.D. +393406462332 luigi.iuliano@uniroma1.it
Contact: Alessandro Polidoro, M.D. +393478115718 alessandro.polidoro@uniroma1.it

Locations
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Italy
ICOT-Sapienza University Hospital Recruiting
Latina, LT, Italy, 04100
Contact: Lugi Iuliano, M.D.    +393406462332    luigi.iuliano@uniroma1.it   
Contact: Alessandro Polidoro, M.D.    +393478115718    alessandro.polidoro@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
ICOT University Hospital
Investigators
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Principal Investigator: Luigi Iuliano, M.D. Sapienza University of Rome
More Information
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Responsible Party: Luigi Iuliano, Professor of Internal Medicine, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04733807    
Other Study ID Numbers: SCAREAID
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luigi Iuliano, University of Roma La Sapienza:
vaccine
Covid-19
safety
Sars-Cov2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases