Covid19Phase 3NCT04564716
Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 in Belarus
A Phase 3 study testing Gam-COVID-Vac in people with Covid19, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 8 sites in Belarus.
Trial summary
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Gam-COVID-Vac
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 8 sitesBelarus
- Study dates
- 28 Sep 2020to 10 Apr 2021
- Phase
- Phase 3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject's written informed consent to participate in the study;
- Male and female subjects between the ages of 18 and 60 years (inclusive).
- A negative test result for HIV, hepatitis, syphilis;
- Negative result of research on antibodies IgM and IgG to SARS Cov2 by enzyme-linked immunosorbent assay;
- A negative result of the COVID-2019 study, as determined by the PCR method at the screening visit;
- Lack of COVID-2019 in anamnesis;
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- Lack of contact of the subject with COVID-2019 patients for at least 14 days before inclusion in the study (according to the participant);
- Agreement to use effective contraceptive methods throughout the study period;
- Negative pregnancy test based on the results of a urine test at a screening visit (for women of childbearing age);
- A negative test for the presence of narcotic substances and psycho-stimulating drugs in the urine at the screening visit;
- Negative alcohol test at the screening visit;
- Lack of pre-existing post-vaccination reactions or post-vaccination complications following the use of immunobiological drugs;
- No acute infectious and/or respiratory diseases for at least 14 days before inclusion in the study.
Who cannot join
- Any vaccination/immunization carried out within 30 days prior to enrollment in the study;
- Treatment with steroids (except hormonal contraceptives) and/or with immunoglobulins or other blood products not completed 30 days before inclusion in the study;
- Immunosuppressive therapy completed less than three months before inclusion in the study;
- Female subjects during pregnancy or breastfeeding;
- Acute coronary syndrome or stroke suffered less than one year before inclusion into the study;
- Tuberculosis, chronic systemic infections;
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- Aggravated allergy anamnesis (anamnesis of anaphylactic shock, Quinque edema, polymorphic exudative eczema, atopia, serum disease), hypersensitivity or allergic reactions to immunobiological drugs, known allergic reactions to the components of the drug, aggravation of allergic diseases on the day of inclusion in the study;
- The presence of neoplasms in the anamnesis (codes C00-D09);
- Donated blood or plasma (450 ml or more) less than 2 months before inclusion in the study;
- Splenectomy in anamnesis;
- Neutropenia (decrease in absolute number of neutrophils less than 1000/mm3), agraneulocytosis, significant haemorrhage, severe anaemia (hemoglobin less than 80 g/l), immunodeficiency in anamnesis for 6 months before inclusion in the study;
- Subjects with an active form of disease caused by human immunodeficiency virus, syphilis, hepatitis B and C;
- Anorexia, protein deficiency of any origin;
- Chronic autoimmune diseases or systemic collagenoses in anamnesis
- Extensive tattoos at the injection site (deltoid region) that do not allow for an assessment of the local response to IMP/placebo administration;
- Alcoholism and drug addiction in anamnesis;
- Participation of the subject in any other interventional clinical trial;
- Any other condition of the subject which, in the opinion of the researcher's medical practitioner, may prevent completion of the investigation according to the protocol;
- Staff of research centers and other staff directly involved in the study and their families.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belarus8 sites
Health Institution "14th Central Regional Polyclinic of the Partisan district of Minsk"
Minsk
Health Institution "19th Central Regional Polyclinic of the Pervomaysk district of Minsk"
Minsk
Health Institution "1st Central Regional Clinical Polyclinic of the Central district of Minsk"
Minsk
Health Institution "28th Regional Polyclinic of Minsk"
Minsk
Health Institution "4th City Polyclinic of Minsk"
Minsk
Health Institution "5th City Clinical Polyclinic of Minsk"
Minsk
Health Institution "Minsk Order of the Red Banner of Labor Regional Clinical Hospital
Minsk
Health Institution "Vitebsk Regional Clinical Hospital"
Vitebsk
About this study
Official title: Сlinical Trial of Efficacy, Safety and Immunogenicity of Combined Vector Vaccine Gam-COVID-Vac in SARS-СoV-2 Infection Prophylactic Treatment in Republic of Belarus
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Read the detailed description
Overall of 110 volunteers aged 18 to 60 should be screened taking into account possible early departure from the study. It is supposed that 100 subjects will complete all screening procedures and will be randomized in a 3:1 ratio into two groups: a control group (using placebo, 25 subjects) and a study group (using Gam-COVID-Vac Combined Vector Vaccine to Prevent Coronavirus Infection Caused by SARS-CoV-2", 75 subjects).
The duration of participation in the study for one subject will be 180±14 days after the first dose of IMP/placebo, during which each subject will undergo a screening visit and five face-to-face visits to the doctor-researcher. Intramuscular injection of IMP or placebo will be carried out on vaccination visits N 1 and N 2 (Day 0 and Day 21±2). Further observation visits No 3, 4, 5 will be conducted on days 28±2, 42±2 and 180±14 respectively. It is allowed to conduct observation visits No. 3, 4 via telephone contact (TC). During the monitoring visits, all subjects of the study will be assessed on key vital indicators and data will be collected on changes in the status and well-being of the subjects since the previous visit.
The duration of participation in the study for one subject will be 180±14 days after the first dose of IMP/placebo, during which each subject will undergo a screening visit and five observation visits. Intramuscular injection of IMP or placebo will be carried out on vaccination visits N 1 and N 2 (Day 0 and Day 21±2). Further observation visits No 3, 4, 5 will be conducted on days 28±2, 42±2 and 180±14 respectively.
- Conditions
- Covid19
- Being tested
- Gam-COVID-Vac, Placebo
- Keywords
- COVID-19, vector vaccine, SARS-CoV-2, adenoviral vector
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gam-COVID-VacBiological
vaccine for intramuscular injection
PlaceboOther
placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Primary Group | Experimental | Gam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S) Receives: Biological: Gam-COVID-Vac |
| Control Group | Placebo comparator | placebo, 0,5ml/dose+0,5 ml/dose immunization in days 1 and 21 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose
Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)
Measured: through the whole study, an average of 180 days
Secondary outcomes (4)
the severity of the clinical course of COVID-19
Assess the efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus compared to placebo, based on the severity of the clinical course of COVID-19
Measured: through the whole study, an average of 180 days
Changing of antibody levels against the SARS-CoV-2 glycoprotein S
Assess the immunogenicity of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the geometric mean titer of SARS-CoV-2 glycoprotein-specific antibodies
Measured: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Incidence of adverse events in trial subjects
Incidence of adverse events in trial subjects compared to placebo
Measured: through the whole study, an average of 180 days
Severity of adverse events in trial subjects
Severity of adverse events in trial subjects compared to placebo
Measured: through the whole study, an average of 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start28 Sep 2020
- Primary completion28 Mar 2021 (estimated)
- Study completion10 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Collaborators
- Russian Direct Investment Fund, CRO: iPharma
- Responsible party
- Sponsor
- Investigators
- Roman Plotnikov, Study chair, CRO: iPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564716
- Sponsor's protocol ID
- 04-Gam-COVID-Vac-2020-RB
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Сlinical Trial of Efficacy, Safety and Immunogenicity of Combined Vector Vaccine Gam-COVID-Vac in SARS-СoV-2 Infection Prophylactic Treatment in Republic of Belarus
- ClinicalTrials.gov ID
- NCT04564716
- Acronym / sponsor ID
- 04-Gam-COVID-Vac-2020-RB
- Conditions
- Covid19
- Keywords
- COVID-19, vector vaccine, SARS-CoV-2, adenoviral vector
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- Russian Direct Investment Fund, CRO: iPharma
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 28 Mar 2021 (estimated)
- Study completion
- 10 Apr 2021 (estimated)
- First posted
- 25 Sep 2020 (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.
Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Detailed description
Overall of 110 volunteers aged 18 to 60 should be screened taking into account possible early departure from the study. It is supposed that 100 subjects will complete all screening procedures and will be randomized in a 3:1 ratio into two groups: a control group (using placebo, 25 subjects) and a study group (using Gam-COVID-Vac Combined Vector Vaccine to Prevent Coronavirus Infection Caused by SARS-CoV-2", 75 subjects).
The duration of participation in the study for one subject will be 180±14 days after the first dose of IMP/placebo, during which each subject will undergo a screening visit and five face-to-face visits to the doctor-researcher. Intramuscular injection of IMP or placebo will be carried out on vaccination visits N 1 and N 2 (Day 0 and Day 21±2). Further observation visits No 3, 4, 5 will be conducted on days 28±2, 42±2 and 180±14 respectively. It is allowed to conduct observation visits No. 3, 4 via telephone contact (TC). During the monitoring visits, all subjects of the study will be assessed on key vital indicators and data will be collected on changes in the status and well-being of the subjects since the previous visit.
The duration of participation in the study for one subject will be 180±14 days after the first dose of IMP/placebo, during which each subject will undergo a screening visit and five observation visits. Intramuscular injection of IMP or placebo will be carried out on vaccination visits N 1 and N 2 (Day 0 and Day 21±2). Further observation visits No 3, 4, 5 will be conducted on days 28±2, 42±2 and 180±14 respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized double-blind placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Primary Group | Experimental | Biological: Gam-COVID-VacGam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S) |
| Control Group | Placebo comparator | Other: Placeboplacebo, 0,5ml/dose+0,5 ml/dose immunization in days 1 and 21 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- The subject's written informed consent to participate in the study;
- Male and female subjects between the ages of 18 and 60 years (inclusive).
- A negative test result for HIV, hepatitis, syphilis;
- Negative result of research on antibodies IgM and IgG to SARS Cov2 by enzyme-linked immunosorbent assay;
- A negative result of the COVID-2019 study, as determined by the PCR method at the screening visit;
Key exclusion criteria (19 listed)
- Any vaccination/immunization carried out within 30 days prior to enrollment in the study;
- Treatment with steroids (except hormonal contraceptives) and/or with immunoglobulins or other blood products not completed 30 days before inclusion in the study;
- Immunosuppressive therapy completed less than three months before inclusion in the study;
- Female subjects during pregnancy or breastfeeding;
- Acute coronary syndrome or stroke suffered less than one year before inclusion into the study;
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 |
|---|---|---|
| Gam-COVID-Vacvaccine for intramuscular injection | Biological | Primary Group |
| Placeboplacebo comparator | Other | Control Group |
Primary outcome
percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose
Time frame: through the whole study, an average of 180 days
Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)
4 secondary outcomes
the severity of the clinical course of COVID-19
Time frame: through the whole study, an average of 180 days
Changing of antibody levels against the SARS-CoV-2 glycoprotein S
Time frame: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Incidence of adverse events in trial subjects
Time frame: through the whole study, an average of 180 days
Severity of adverse events in trial subjects
Time frame: through the whole study, an average of 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
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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.
Roman Plotnikov study chair
CRO: iPharma
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gam-COVID-Vac in people with Covid19, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 8 sites 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 13 inclusion and 19 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose (time frame: through the whole study, an average of 180 days). 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 2 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.