Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study

SARS-CoV2 Infection Clinical Trial

— DANTE-SIRIO 7  

Official title:

Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination (DANTE-SIRIO 7) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05109585
• Other study ID #: DANTE- SIRIO 7
• Status: Active, not recruiting
• Start date: April 20, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Collegium Medicum w Bydgoszczy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Great expectations to control the pandemic are placed in vaccines against COVID-19. Currently, the four COVID-19 vaccines approved in the European Union. We have designed the study assessing the anti-SARS-CoV-2 IgG antibody titer after vaccination cycle the BNT162b2 vaccine in several time points relating these results to the COVID-19 history and severity of symptoms during the disease and after the first and second vaccine dose

Description:

The study includes healthy, unselected volunteers from the staff of Antoni Jurasz University Hospital No.1 in Bydgoszcz and students of Collegium Medicum, Nicolaus Copernicus University. To meet the inclusion criteria patients will have to be vaccinated with two doses of the BNT162b2 vaccine. The assessment of the anti-SARS-CoV-2 IgG antibody titer at several time points in each participant. Fresh serum samples were used to measure SARS-CoV-2 IgG on the Siemens Atellica system (Siemens Healthineers, Erlangen, Germany). Results of SARS-CoV-2 IgG were given as U/ml, whereby the cut-off for positivity was defined as ≥1.0 U/ml.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provision of informed consent to study
• Age = 18 years
• Receiving two doses of the BNT162b2 vaccine

Exclusion Criteria:

• patients who did not complete 2-dose vaccination schedule
• patients who received any other vaccine than BNT162b2
• patients considered by investigator to be unable to cooperate

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2 Infection

Intervention

Diagnostic Test:
• assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule
evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule willing to receive a 3rd dose of vaccine
• assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule
evaluation of anti-SARS-CoV-2 IgG antibodies in patients after 2-dose vaccination schedule unwilling to receive a 3rd dose of vaccine

Locations

Country	Name	City	State
Poland	Cardiology Department, Dr. A. Jurasz University Hospital	Bydgoszcz	Kujawsko-Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Collegium Medicum w Bydgoszczy

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the anti-SARS-CoV-2 IgG antibody concentration 3 months after vaccination cycle with the BNT162b2 vaccine	evaluation of anti-SARS-CoV-2 IgG antibody concentration 3 months after 2-dose vaccination with BNT162b2 vaccine	0-12 months
Secondary	the anti-SARS-CoV-2 IgG antibody concentration 6, 9 and 12 months after two-dose vaccination cycle	evaluation of anti-SARS-CoV-2 IgG antibody concentration at particular time points in 2-dose vaccination schedule	0-12 months
Secondary	the anti-SARS-CoV-2 IgG antibody concentration immediately before, 1 and 3 months after the third vaccine dose	evaluation of anti-SARS-CoV-2 IgG antibody concentration at particular time points after 3rd dose of vaccine	0-12 months
Secondary	local and/or systemic adverse reactions after vaccination	verification of any adverse events occurrence based on survey filled by participants on each visit	0-12 months
Secondary	confirmed COVID-19 after vaccination	verification of COVID-19 based on survey filled by participants on each visit	0-12 months