Humoral Immunity Study After Booster Vaccination of "Soberana Plus" (The Republic of Cuba) Against COVID-19

January 26, 2023 updated by: Gomel State Medical University
To evaluate the dynamics of IgG levels to the SARS-CoV-2 virus after a booster dose of Soberana Plus vaccine.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Gomel, Belarus, 246050
        • Gomel State Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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, Republic of Cuba)
Biological: Protein subunit vaccine Soberana Plus S, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.
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, Republic of Cuba)
Biological: Protein subunit vaccine Soberana Plus S, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.
Booster dose administration

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2022

Primary Completion (Anticipated)

March 10, 2023

Study Completion (Anticipated)

July 28, 2023

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GomelSMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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