Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05689177
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-02-01
First Post:
2023-01-16
Brief Title:
Humoral Immunity Study After a Booster Dose of Soberana Plus FINLAY-FR-1A Vaccine Against COVID-19
Sponsor:
Gomel State Medical University
Organization:
Gomel State Medical University
Study Overview
Official Title:
Humoral Immunity Study After a Booster Dose of Soberana Plus FINLAY-FR-1A Vaccine Against COVID-19 Republic of Cuba
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 202217065Т 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 code20136 and expressed in international units BAUml
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 BAUml 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 10 BAUml
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 202217065Т 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 code20136 and expressed in international units BAUml
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 BAUml 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 10 BAUml
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None