MERS (Middle East Respiratory Syndrome)Phase 1/2NCT04128059
Study of Safety and Immunogenicity of BVRS-GamVac-Combi
A Phase 1/2 study testing BVRS-GamVac-Combi in people with MERS (Middle East Respiratory Syndrome) and MERS, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial summary
The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- MERS (Middle East Respiratory Syndrome), MERS
- What is being tested?
- BVRS-GamVac-Combi
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteRussia
- Study dates
- 6 Nov 2019to 31 Dec 2021
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Volunteer participation in any other study over the past 90 days;
- Any vaccination in the last 30 days;
- Acute infectious and non-infectious diseases, exacerbations of chronic diseases within 4 weeks prior to screening;
- subject has received treatment with steroids for the last 10 days;
- subject has received immunoglobulins or other blood products over the last 3 months;
- subject has received immunosuppressive and/or immunomodulating agents within 6 months prior to the start of the study;
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- Pregnancy or lactation;
- subject has systolic blood pressure less than 100 mm Hg or greater than 139 mm Hg; diastolic blood pressure less than 60 mm Hg or greater than 90 mm Hg; heart rate lower than 60 beats per minute or above 100 beats per minute;
- A burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, a history of serum sickness, hypersensitivity or allergic reactions to the introduction of any vaccines in history, known allergic reactions to vaccine components, etc.);
- Diabetes mellitus or other forms of impaired glucose tolerance;
- presence of a concomitant illness in decompensation stage which might affect the course of the study (CNS organic lesion, decompensated cardiovascular diseases, any manifestations of kidney or acute liver failure, oncological diseases, diabetes mellitus);
- subject has a a history of neoplasms (ICD codes C00-D09);
- blood donation (at least 450 ml of blood or plasma) by subject in less than 2 months prior to the start of the study;
- Reception of narcotic and psychostimulating drugs at present or in the anamnesis;
- subject has a history of the consumption of more than 5 units alcohol per week, alcohol intake within 48 hours before the injection of the test drug;
- subject smokes more than 10 cigarettes a day;
- subject has a planned hospitalization and / or surgery during the period of participation in the study, as well as 4 weeks before the estimated date of vaccination.
- subject has any condition that, according to the researcher's doctor, may be a contraindication to participation in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
ECO-Safety
Saint Petersburg
Tatiana Zubkova, MD, PhD
About this study
Official title: Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac-Combi", a Combined Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers
The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%.
The aim of the study is to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.
Read the detailed description
The study will include volunteers of both sexes, aged 18-55 years inclusive. The study will involve 268 (will receive the vaccine or placebo) healthy volunteers.
At the first stage, it is planned:
- study the safety of component 1 - 40 volunteers and 4 spares *
- study the safety of prime-boost vaccination with component 1 and component 2 with an interval of 21 days in half and full dose - 40 volunteers and 4 spares * At the second phase, it is planned to study the safety and immunogenicity of the vaccine as part of a placebo-controlled randomized trial - 188 people, of whom 138 will receive the vaccine, and 50 will make up the control group of observation - they will be given a placebo. Data from 20 volunteers from the first phase who received the drug in selected dose will be included in the analysis of safety and immunogenicity of the second phase.
- Volunteers are replaced by spares before the introduction of the drug, if the volunteer took the drug, then the replacement is not performed.
Any volunteer who received a dose of the vaccine will be considered as included in the study, the data available on it will be used in assessing the safety and tolerability of the drug.
- Conditions
- MERS (Middle East Respiratory Syndrome), MERS
- Being tested
- BVRS-GamVac-Combi, placebo
- Keywords
- vaccine, vector based vaccine, Immunologic Factors, MERS-CoV, Middle East respiratory syndrome
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVRS-GamVac-CombiDrug
"BVRS-GamVac-Combi", a combined vector vaccine for the prevention of Middle East respiratory syndrome, lyophilisate for the preparation of a solution for intramuscular administration
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| phase 1, component 1 | Experimental | component 1 of vaccine Receives: Drug: BVRS-GamVac-Combi |
| phase 1, half dose | Experimental | prime-boost vaccination with component 1 and component 2 with an interval of 21 days in half dose Receives: Drug: BVRS-GamVac-Combi |
| phase 1, full dose | Experimental | prime-boost vaccination with component 1 and component 2 with an interval of 21 days in full dose Receives: Drug: BVRS-GamVac-Combi |
| phase 2, selected dose | Experimental | prime-boost vaccination with component 1 and component 2 with an interval of 21 days in selected dose Receives: Drug: BVRS-GamVac-Combi |
| phase 2, placebo | Placebo comparator | vaccination with placebo with an interval of 21 days Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Determination of Number of Participants With Adverse Events
Measured: through the whole study, an average of 180 days
Number of Participants With Serious Adverse Events
Determination of Number of Participants With Serious Adverse Events
Measured: through the whole study, an average of 180 days
Number of Participants with Solicited Local and Systemic Adverse Events
Determination of Number of Participants with Solicited Local and Systemic Adverse Events
Measured: through the whole study, an average of 180 days
Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA)
Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)
Measured: Time Frame for group 1 phase 1: at days 0, 7, 14, 21, 28, 42, 56 and 90. Time Frame for group 2 phase 1 and phase 2: at days 0, 7, 14, 21, 28, 35, 42, 56 and 90
Secondary outcomes (2)
Assessment of antigen-specific cell-mediated immune response
determination of specific T-cell- mediated response vs. baseline values and placebo
Measured: at 0, 14 and 28 days from the start of vaccination compared to baseline values (phase 1, phase 2) and placebo (phase 2)
Neutralizing antibody levels
Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values and placebo
Measured: at days 0, 14 and 28 from the start of vaccination compared to baseline values
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start6 Nov 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MERS (Middle East Respiratory Syndrome)Studies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 268 participants (estimated)
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
- Acellena Contract Drug Research and Development
- Responsible party
- Sponsor
- Investigators
- Tatiana Zubkova, MD, PhD, Principal investigator, ECO-Safety
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128059
- Sponsor's protocol ID
- 02-BVRS-GamVac-Combi-2019
- Status last verified
- Jan 2021
- First submitted
- 14 Oct 2019
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- 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 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac-Combi", a Combined Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04128059
- Acronym / sponsor ID
- 02-BVRS-GamVac-Combi-2019
- Conditions
- MERS (Middle East Respiratory Syndrome), MERS
- Keywords
- vaccine, vector based vaccine, Immunologic Factors, MERS-CoV, Middle East respiratory syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- Acellena Contract Drug Research and Development
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Oct 2019 (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.
The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%.
The aim of the study is to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.
Detailed description
The study will include volunteers of both sexes, aged 18-55 years inclusive. The study will involve 268 (will receive the vaccine or placebo) healthy volunteers.
At the first stage, it is planned:
- study the safety of component 1 - 40 volunteers and 4 spares *
- study the safety of prime-boost vaccination with component 1 and component 2 with an interval of 21 days in half and full dose - 40 volunteers and 4 spares * At the second phase, it is planned to study the safety and immunogenicity of the vaccine as part of a placebo-controlled randomized trial - 188 people, of whom 138 will receive the vaccine, and 50 will make up the control group of observation - they will be given a placebo. Data from 20 volunteers from the first phase who received the drug in selected dose will be included in the analysis of safety and immunogenicity of the second phase.
- Volunteers are replaced by spares before the introduction of the drug, if the volunteer took the drug, then the replacement is not performed.
Any volunteer who received a dose of the vaccine will be considered as included in the study, the data available on it will be used in assessing the safety and tolerability of the drug.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| phase 1, component 1 | Experimental | Drug: BVRS-GamVac-Combicomponent 1 of vaccine |
| phase 1, half dose | Experimental | Drug: BVRS-GamVac-Combiprime-boost vaccination with component 1 and component 2 with an interval of 21 days in half dose |
| phase 1, full dose | Experimental | Drug: BVRS-GamVac-Combiprime-boost vaccination with component 1 and component 2 with an interval of 21 days in full dose |
| phase 2, selected dose | Experimental | Drug: BVRS-GamVac-Combiprime-boost vaccination with component 1 and component 2 with an interval of 21 days in selected dose |
| phase 2, placebo | Placebo comparator | Other: placebovaccination with placebo with an interval of 21 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Volunteer participation in any other study over the past 90 days;
- Any vaccination in the last 30 days;
- Acute infectious and non-infectious diseases, exacerbations of chronic diseases within 4 weeks prior to screening;
- subject has received treatment with steroids for the last 10 days;
- subject has received immunoglobulins or other blood products over the last 3 months;
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 |
|---|---|---|
| BVRS-GamVac-Combi"BVRS-GamVac-Combi", a combined vector vaccine for the prevention of Middle East respiratory syndrome, lyophilisate for the preparation of a solution for intramuscular administration | Drug | phase 1, component 1, phase 1, full dose, phase 1, half dose, phase 2, selected dose |
| placeboplacebo | Other | phase 2, placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: through the whole study, an average of 180 days
Determination of Number of Participants With Adverse Events
Number of Participants With Serious Adverse Events
Time frame: through the whole study, an average of 180 days
Determination of Number of Participants With Serious Adverse Events
Number of Participants with Solicited Local and Systemic Adverse Events
Time frame: through the whole study, an average of 180 days
Determination of Number of Participants with Solicited Local and Systemic Adverse Events
Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA)
Time frame: Time Frame for group 1 phase 1: at days 0, 7, 14, 21, 28, 42, 56 and 90. Time Frame for group 2 phase 1 and phase 2: at days 0, 7, 14, 21, 28, 35, 42, 56 and 90
Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)
2 secondary outcomes
Assessment of antigen-specific cell-mediated immune response
Time frame: at 0, 14 and 28 days from the start of vaccination compared to baseline values (phase 1, phase 2) and placebo (phase 2)
Neutralizing antibody levels
Time frame: at days 0, 14 and 28 from the start of vaccination compared to baseline values
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
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.
Tatiana Zubkova, MD, PhD principal investigator
ECO-Safety
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BVRS-GamVac-Combi in people with MERS (Middle East Respiratory Syndrome) and MERS, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
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 0 inclusion and 18 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 14 Jan 2021. 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 Russia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Inna Dolzhikova, PhD (1933001, info@gamaleya.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: through the whole study, an average of 180 days). The study lists 4 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 14 Jan 2021.