NCT04733807

Antibodies Response to mRNA Vaccine Against Covid-19

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Covid-19

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2 mRNA Covid-19 Vaccine	Hospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response.

Timeline

• Start date: 2021-01-28
• Primary completion: 2021-07-31
• Completion: 2022-02-01
• First posted: 2021-02-02
• Last updated: 2021-05-11

Locations

1 site across 1 country: Italy