Antibodies Response to mRNA Vaccine Against Covid-19

• Conditions: Covid-19

• Registration Number: NCT04733807
• Lead Sponsor: University of Roma La Sapienza

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.

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 Timeline

• Study Start: 2021-01-28
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-31
• Study First Posted: 2021-02-02
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11
• Primary Completion: 2021-07-31
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Hospital employers vaccinated against Sars-Cov2

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum IgG antibodies levels in response to vaccine	Serum antibody at 12 months	Determination of IgG levels in serum

Secondary Outcome Measures

Name	Time	Method
Sars-Cov2 infection in vaccinated subjects	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.
Covid-19 disease in vaccinated subjects	Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year.	Monitoring the occurrence of Covid-19 disease in vaccinated people

Trial Locations

Locations (1)

ICOT-Sapienza University Hospital; 🇮🇹 Latina, LT, Italy