Humoral Immunity Study After a Booster Dose of Soberana Plus (FINLAY-FR-1A) Vaccine Against COVID-19

Study Overview
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Brief Summary
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To evaluate the dynamics of IgG levels to the SARS-CoV-2 virus after a booster dose of Soberana Plus vaccine.

Detailed Description
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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.

Official Title
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Humoral Immunity Study After a Booster Dose of Soberana Plus (FINLAY-FR-1A) Vaccine Against COVID-19 (Republic of Cuba)

Conditions
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Humoral Immunity

Intervention / Treatment
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* Biological: Protein 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)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 y.o.; More that 4 months after the previous vaccination against COVID-19; No COVID-19 infection registered within 30 days prior to Soberana Plus administration. Exclusion Criteria: Age less than 18 y.o. or more than 80 y.o.; Less than 4 months after the previous vaccination against COVID-19; COVID-19 infection registered within 30 days prior to Soberana Plus administration.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Booster dose administration to younger participants<br>Participants 18-25 y.o. take a booster dose of vaccine against COVID-19 (Soberana Plus (FINLAY-FR-1A), Republic of Cuba) | Biological: Protein 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)<br>* Booster dose administration<br>|
| Experimental: Booster dose administration to older participants<br>Participants 26-80 y.o. take a booster dose of vaccine against COVID-19 (Soberana Plus (FINLAY-FR-1A) Republic of Cuba) | Biological: Protein 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)<br>* Booster dose administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG level assessment | The quantification of the SARS-CoV-2 antibody assay | 42 days after booster dose administration | 
| IgG level assessment | The quantification of the SARS-CoV-2 antibody assay | 90 days after booster dose administration | 
| IgG level assessment | The quantification of the SARS-CoV-2 antibody assay | 180 days after booster dose administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, Humoral immunity, Booster dose