Determinants of the level of anti-SARSCoV- 2 IgG ANTibodiEs after vaccination (DANTE-SIRIO 7) study. A rationale and protocol of the study

Abstract

Introduction: Great expectations to control the pandemic are placed on vaccines against COVID-19. So far, four COVID-19 vaccines have been approved for use in the European Union. This study aimed to assess the anti-SARS-CoV-2 IgG antibody concentration after the vaccination cycle with the BNT162b2 vaccine at several predefined time points. All results will be compared to the COVID-19 history and severity of symptoms during the disease and after the first and second vaccine dose. Material and methods: The study includes healthy, unselected volunteers from the staff of Dr. Antoni Jurasz University Hospital No.1 in Bydgoszcz and students of the Collegium Medicum, Nicolaus Copernicus University. To meet the inclusion criteria all individuals will have to be vaccinated with two doses of the BNT162b2 (BioNTech/Pfizer, US) vaccine. Anti-SARS-CoV-2 IgG antibody concentrations will be measured in fresh serum samples collected from each participant at predefined time points. All measurements will be performed using the Atellica system (Siemens Healthineers, Erlangen, Germany). Results of SARS-CoV-2 IgG are given as U/mL, whereby the cut-off for positivity is defined as ≥ 1.0 U/mL. Discussion: This study was designed to evaluate the impact of COVID-19 on the severity of clinical symptoms and the levels of anti-SARS-CoV-2 IgG antibodies after vaccination. Hopefully, based on its results, further clinical outcome-powered trials will be designed and conducted to elucidate how quantitative antibody levels can be used as a correlate of vaccine-mediated protection.