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

Humoral Immunity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05689177
• Other study ID #: GomelSMU
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 9, 2022
• Est. completion date: July 28, 2023

Study information

• Verified date: January 2023
• Source: Gomel State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 28, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Humoral Immunity

Intervention

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)
Booster dose administration

Locations

Country	Name	City	State
Belarus	Gomel State Medical University	Gomel

Sponsors (1)

Lead Sponsor	Collaborator
Gomel State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgG level assessment	The quantification of the SARS-CoV-2 antibody assay	42 days after booster dose administration
Primary	IgG level assessment	The quantification of the SARS-CoV-2 antibody assay	90 days after booster dose administration
Primary	IgG level assessment	The quantification of the SARS-CoV-2 antibody assay	180 days after booster dose administration