Humoral ImmunityNCT05689177
Humoral Immunity Study After a Booster Dose of Soberana Plus (FINLAY-FR-1A) Vaccine Against COVID-19
A study testing 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) in people with Humoral Immunity, run by Gomel State Medical University at 1 site in Belarus.
Trial summary
To evaluate the dynamics of IgG levels to the SARS-CoV-2 virus after a booster dose of Soberana Plus vaccine. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Humoral Immunity
- What is being tested?
- 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)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelarus
- Study dates
- 9 Dec 2022to 28 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Humoral Immunity Study After a Booster Dose of Soberana Plus (FINLAY-FR-1A) Vaccine Against COVID-19 (Republic of Cuba)
To evaluate the dynamics of IgG levels to the SARS-CoV-2 virus after a booster dose of Soberana Plus vaccine.
Read the 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.
- Conditions
- Humoral Immunity
- Being tested
- 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)
- Keywords
- COVID-19, SARS-CoV-2, Humoral immunity, Booster dose
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Biological
Booster dose administration
| Study group | Role | What they receive |
|---|---|---|
| Booster dose administration to younger participants | Experimental | Participants 18-25 y.o. take a booster dose of vaccine against COVID-19 (Soberana Plus (FINLAY-FR-1A), Republic of Cuba) Receives: 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 to older participants | Experimental | Participants 26-80 y.o. take a booster dose of vaccine against COVID-19 (Soberana Plus (FINLAY-FR-1A) Republic of Cuba) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG level assessment
The quantification of the SARS-CoV-2 antibody assay
Measured: 42 days after booster dose administration
IgG level assessment
The quantification of the SARS-CoV-2 antibody assay
Measured: 90 days after booster dose administration
IgG level assessment
The quantification of the SARS-CoV-2 antibody assay
Measured: 180 days after booster dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start9 Dec 2022
- Primary completion10 Mar 2023 (estimated)
- Study completion28 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humoral ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gomel State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor Stoma, MD, Study chair, Gomel state medical university, Gomel, Province, Belarus, 246000Olga Osipkina, Principal investigator, Gomel State Medical University, Gomel, Province, Belarus, 246000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689177
- Sponsor's protocol ID
- GomelSMU
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humoral Immunity Study After a Booster Dose of Soberana Plus (FINLAY-FR-1A) Vaccine Against COVID-19 (Republic of Cuba)
- ClinicalTrials.gov ID
- NCT05689177
- Acronym / sponsor ID
- GomelSMU
- Conditions
- Humoral Immunity
- Keywords
- COVID-19, SARS-CoV-2, Humoral immunity, Booster dose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gomel State Medical UniversityUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 10 Mar 2023 (estimated)
- Study completion
- 28 Jul 2023 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Booster dose administration to younger participants | Experimental | 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)Participants 18-25 y.o. take a booster dose of vaccine against COVID-19 (Soberana Plus (FINLAY-FR-1A), Republic of Cuba) |
| Booster dose administration to older participants | Experimental | 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)Participants 26-80 y.o. take a booster dose of vaccine against COVID-19 (Soberana Plus (FINLAY-FR-1A) Republic of Cuba) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Booster dose administration to older participants, Booster dose administration to younger participants |
Primary outcome
IgG level assessment
Time frame: 42 days after booster dose administration
The quantification of the SARS-CoV-2 antibody assay
IgG level assessment
Time frame: 90 days after booster dose administration
The quantification of the SARS-CoV-2 antibody assay
IgG level assessment
Time frame: 180 days after booster dose administration
The quantification of the SARS-CoV-2 antibody assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Stoma, MD study chair
Gomel state medical university, Gomel, Province, Belarus, 246000
Olga Osipkina principal investigator
Gomel State Medical University, Gomel, Province, Belarus, 246000
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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) in people with Humoral Immunity, run by Gomel State Medical University at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG level assessment (time frame: 42 days after booster dose administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.