Humoral Immunity
Conditions
Keywords
COVID-19, SARS-CoV-2, Humoral immunity, Booster dose
Brief summary
To evaluate the dynamics of IgG levels to the SARS-CoV-2 virus after a booster dose of Soberana Plus vaccine.
Detailed description
Prospective clinical study of evaluation of the immune response to booster dose of vaccine against COVID-19 using enzyme immunoassay using the Sunrise Tecan microplate photometer (Austria). The material is participants' plasma, obtained by the standard method. Blood sampling performed 4 times: immediately before the first dose of vaccine, on day 42, 90 days and 180 days after booster dose of vaccine. Booster dose of vaccine against coronavirus infection performing using approved and licensed vaccine Soberana Plus (Republic of Cuba). Venous blood sampling performing standardly. All study participants are informed about the study objectives and upcoming procedures, and all of them given informed written consent to participate the study. A reagent kit manufactured by Vector-Best (Russian Federation) and designed for enzyme immunoassay for quantitative detection of SARS-CoV-2 class G immunoglobulins, SARS-CoV-2-IgG quantitative ELISA-BEST, D-5505 SARS-CoV-2-IgG (series 5, 6) РУ № РЗН 2022/17065Т used for immunoassay. The SARS-CoV-2-IgG quantitative ELISA-BEST reagent kit design uses recombinant full-length trimerized S glycoprotein (Spike) of the SARS-CoV-2 virus derived from a eukaryotic expression system. The protein molecule+ consists of two subunits, S1 containing the RBD domain and S2. The reagent kit SARS-CoV-2-IgG quantitative ELISA-BEST detects the pool of immunoglobulin class G synthesized to all antigenic determinants of protein S including the RBD-domain. The quantification of the SARS-CoV-2 antibody assay is based on the WHO First International Standard (NIBSC code:20/136) and expressed in international units (BAU/ml). Analytical characteristics of reagent kit SARS-CoV-2-IgG quantitative ELISA-BEST (series 5, 6) were: Linearity - within 90-110%, considering the analytical results at wavelengths 405 nm and 415 nm - within the concentration range IgG к SARS-CoV-2 10-5000 BAU/ml; Reproducibility: the coefficient of variation does not exceed 8%). The opening test - within 90-110% (samples with absorbances lower than 90% of the cut-off value are considered negative and samples with absorbances higher than 110% of the cut-off value are considered positive. The samples with absorbance in the range of 90-110% of cut-off value are equivocal). Analytical sensitivity - minimal detectable concentration of IgG to SARS-CoV-2 does not exceed 1.0 BAU/ml.
Interventions
BIOLOGICALProtein subunit vaccine Soberana Plus (FINLAY-FR-1A) is a vaccine against COVID-19 produced by The Finlay Vaccine Institute and The Centre of Molecular Immunology (Republic of Cuba)
Booster dose administration
Sponsors
Gomel State Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-80 y.o.; 2. More that 4 months after the previous vaccination against COVID-19; 3. No COVID-19 infection registered within 30 days prior to Soberana Plus administration.
Exclusion criteria
1. Age less than 18 y.o. or more than 80 y.o.; 2. Less than 4 months after the previous vaccination against COVID-19; 3. COVID-19 infection registered within 30 days prior to Soberana Plus administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IgG level assessment | 42 days after booster dose administration | The quantification of the SARS-CoV-2 antibody assay |
Countries
Belarus
Outcome results
None listed