Antibodies Response to mRNA Vaccine Against Covid-19

Covid-19 Clinical Trial

— SCAREAID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04733807
• Other study ID #: SCAREAID
• Status: Recruiting
• Start date: January 28, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: May 2021
• Source: University of Roma La Sapienza
• Contact: Lugi Iuliano, M.D.
• Phone: +393406462332
• Email: luigi.iuliano[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 1, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Hospital employers vaccinated against Sars-Cov2

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Covid-19

Intervention

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

Locations

Country	Name	City	State
Italy	ICOT-Sapienza University Hospital	Latina	LT

Sponsors (2)

Lead Sponsor	Collaborator
University of Roma La Sapienza	ICOT University Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum IgG antibodies levels in response to vaccine	Determination of IgG levels in serum	Serum antibody at 1 month
Primary	Serum IgG antibodies levels in response to vaccine	Determination of IgG levels in serum	Serum antibody at 3 months
Primary	Serum IgG antibodies levels in response to vaccine	Determination of IgG levels in serum	Serum antibody at 6 months
Primary	Serum IgG antibodies levels in response to vaccine	Determination of IgG levels in serum	Serum antibody at 12 months
Secondary	Sars-Cov2 infection in vaccinated subjects	Monitoring of Sars-Cov2 infection by a nasopharyngeal swab of spike protein Ag, and PCR confirmation in case of Ag swab positivity.	up to 12 months
Secondary	Covid-19 disease in vaccinated subjects	Monitoring the occurrence of Covid-19 disease in vaccinated people	Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year.