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

U

University of Roma La Sapienza

Status

Unknown

Conditions

Covid-19

Treatments

Biological: BNT162b2 mRNA Covid-19 Vaccine

Study type

Observational

Funder types

Other

Identifiers

NCT04733807
SCAREAID

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Hospital employers vaccinated against Sars-Cov2

Exclusion criteria

  • none

Trial contacts and locations

1

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Central trial contact

Lugi Iuliano, M.D.; Alessandro Polidoro, M.D.

Data sourced from clinicaltrials.gov

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