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

• Sponsor: Gomel State Medical University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05689177
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.6
• Patients Per Site Per Month: 13.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Humoral Immunity	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)	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Humoral Immunity Study After a Booster Dose of Soberana Plus (FINLAY-FR-1A) Vaccine Against COVID-19 (Republic of Cuba)
• Actual Study Start Date: Dec 9, 2022
• Anticipated Primary Completion Date: Mar 10, 2023
• Anticipated Study Completion Date: Jul 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Booster dose administration to younger participants 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); Booster dose administration
Experimental: Booster dose administration to older participants 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); Booster dose administration

Outcome Measures

Primary Outcome Measures

1. IgG level assessment [42 days after booster dose administration]

   The quantification of the SARS-CoV-2 antibody assay

2. IgG level assessment [90 days after booster dose administration]

   The quantification of the SARS-CoV-2 antibody assay

3. IgG level assessment [180 days after booster dose administration]

   The quantification of the SARS-CoV-2 antibody assay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gomel State Medical University	Gomel		Belarus	246050

Sponsors and Collaborators

• Gomel State Medical University

Investigators

• Study Chair: Igor Stoma, MD, Gomel state medical university, Gomel, Province, Belarus, 246000
• Principal Investigator: Olga Osipkina, Gomel State Medical University, Gomel, Province, Belarus, 246000

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gomel State Medical University
• ClinicalTrials.gov Identifier: NCT05689177
• Other Study ID Numbers: GomelSMU
• First Posted: Jan 19, 2023
• Last Update Posted: Feb 1, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gomel State Medical University: COVID-19; SARS-CoV-2; Humoral immunity; Booster dose
• Additional relevant MeSH terms: COVID-19; Vaccines

Study Results

No Results Posted as of Feb 1, 2023