Antibodies Response to mRNA Vaccine Against Covid-19

NCT ID: NCT04733807

Last Updated: 2021-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-28

Study Completion Date

2022-02-01

Brief Summary

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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

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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.

Conditions

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Covid-19

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Interventions

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BNT162b2 mRNA Covid-19 Vaccine

Hospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Hospital employers vaccinated against Sars-Cov2

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ICOT University Hospital

UNKNOWN

Sponsor Role collaborator

University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Luigi Iuliano

Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luigi Iuliano, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

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ICOT-Sapienza University Hospital

Latina, LT, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Lugi Iuliano, M.D.

Role: CONTACT

+393406462332

Alessandro Polidoro, M.D.

Role: CONTACT

+393478115718

Facility Contacts

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Lugi Iuliano, M.D.

Role: primary

+393406462332

Alessandro Polidoro, M.D.

Role: backup

+393478115718

Other Identifiers

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SCAREAID

Identifier Type: -

Identifier Source: org_study_id

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