Healthy VolunteersPhase 1/2NCT03333538
A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of GamEvac-Lyo
A Phase 1/2 study testing GamEvac-Lyo (component A), GamEvac-Lyo (component B) and GamEvac-Lyo in people with Healthy Volunteers, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial summary
The purpose of this study is to evaluate immunogenicity and safety of medicinal product GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GamEvac-Lyo (component A), GamEvac-Lyo (component B) and GamEvac-Lyo
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteRussia
- Study dates
- 3 Nov 2017to 31 Dec 2018
- 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
- males and females within the age range from 18 to 55 years;
- written informed consent;
- subject body mass index (BMI): 18.5 ≤ BMI ≤ 30
- subject agrees to use effective contraceptive methods during the entire period of participation in the study (one of the following methods will be used: sexual abstinence; condoms (male or female with or without spermicidal agent); diaphragm or cervical cap with spermicidal agent; intrauterine device);
- absence of severe allergic diseases in the medical history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum disease)
- absence of allergic diseases relapses
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- absence of acute infectious diseases/relapses of chronic diseases at the time of vaccine administration and 7 days prior to the vaccination
- no serious post-vaccination complications in patient's history following the earlier administration of immunobiological products
- in medical history and based on the screening results, subject has no diseases of the gastrointestinal system, liver, kidneys, cardiovascular system, CNS, locomotion system, urogenital and endocrine systems that could affect the assessment of the study results
- subject has a negative result of the blood or urine pregnancy test (for females of childbearing age)
- subject has negative tests for HIV, hepatitis B and С, syphilis
- subject has a negative result of the urine test for residual narcotic drugs
- subject has no hematopoietic malignancies
- subject has no malignant neoplasms
- indicators of complete blood count test at a screening visit are not heigher/lower from 1,1*ULN/LLN (upper limit of normal/lower limit of normal)
- indicators of clinical biochemical analysis at a screening visit: blood urea nitrogen, creatinine, glutamic-pyruvic transaminase, glutamate-oxaloacetate-transaminase, blood glucose test, creatinkinase, total protein, bilirubin are not heigher/lower from 1,1*ULN/LLN (upper limit of normal/lower limit of normal). Total cholesterol level from 3,6 mmol/L to 7,8 mmol/L.
- absence of inflammatory or dystrophic myocardial changes based on ECG data.
- absence of previous immunization with any vaccine against Ebola virus disease based on medical history data and during clinical trials as well
Who cannot join
- volunteer involvement in another study over the last 90 days
- any immunization with vaccine over the last 30 days
- 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 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 90 beats per minute
- any clinically significant laboratory abnormalities
- subject has received treatment with steroids for the last 10 days
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- subject has received immunoglobulins or other blood products over the last 3 months
- patient unwillingness to participate in the study
- blood donation (at least 450 ml of blood or plasma) by subject in less than 2 months prior to the start of the study
- subject has a history of the consumption of more than 5 units (0.25 l of pure alcohol) a week or drug abuse
- subject smokes more than 10 cigarettes a day
- positive results of urine test for narcotic drug residues
- positive result of breath alcohol test (in the expired air sample)
- subject has no ability to understand or follow the Protocol instructions
- patient unwillingness to follow the procedures
- pregnancy or breast feeding
- subject has received immunosuppressive and/or immunomodulating agents within 6 months prior to the start of the study
- history of regular injection or intranasal drug use; injection or intranasal drug use at the present time
- subject has experienced symptoms of respiratory disease for the last 3 days
- subject has exacerbation of allergic diseases or history of anaphylactic reactions or angioneurotic edema
- previous history of hypersensitivity or allergic reactions to the administration of any vaccines
- allergic reactions to the vaccine components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of Medicinal Product GamEvac-Lyo, Vector-Based Vaccine Against Ebola Virus Disease, Lyophilisate for Preparation of Solution for Intramuscular Injection
The purpose of this study is to evaluate immunogenicity and safety of medicinal product GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease
Read the detailed description
This clinical trial is designed as a double blind randomized placebo-controlled study to evaluate immunogenicity of medicinal product GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease The study will consist of two stages. At the first stage in this research is planned to study the safety and tolerability of one dose of component A and B combined vaccine vector against Ebola in 20 healthy volunteers: 10 for component A and 10 to component B. In the first stage, the placebo will not be used. The duration of screening up to 10 days.
Volunteers at the first stage will receive the drug 1 time on the first day of the study. On the third day of the study (48 hours after administration of the vaccine) they will be discharged from the hospital. There will also be 1 outpatient visit on day 7 after drug administration.
After interim analysis of safety data is subject to the consent of the local ethics Committee of the Research Centre about the possibility of further studies of the drug - will be started the second phase of the study, which, along with continued security research, provides the definition of the parameters of immunogenicity of the study drug. The second phase of the study will included 200 participants, including 150 people will receive the study drug and 50 will be a control group of observation - that is, will get a placebo.
Study Schedule Visit 0 (outpatient): screening Visit 1 (inpatient): Immunization with component A/placebo (observation at the hospital for 48 hours). Local adverse reactions will be monitored during the entire observation period; on the day of immunization - local and systemic reactions should be recorded 20 minutes, 5 and 8 hours after the vaccine administration. Later, in-hospital local and systemic adverse reactions to the product will be documented during physical examinations twice a day (morning and evening) and also prior the subjects are discharged from the hospital. Adverse events will be then recorded in the "Daily Diaries" kept by the subjects during the outpatient stage.
Visit 2: Day 7 after the first vaccine administration - outpatient setting. Visit 3 (inpatient) (Day 21) Immunization with component B/placebo (observation at the hospital for 48 hours): Local adverse reactions will be monitored during the entire observation period; on the day of immunization - local and systemic reactions should be recorded 20 minutes, 5 and 8 hours after the vaccine administration. Later, in-hospital local and systemic adverse reactions to will be documented during physical examinations twice a day (morning and evening) and also before the subjects are discharged from the hospital. Adverse events will be recorded in the "Daily Diaries" kept by the subjects during the outpatient stage.
Visits #4, 5, 6 - will be held in outpatient settings on Days 28 , 42 and 90 after the vaccine administration.
- Conditions
- Healthy Volunteers
- Being tested
- GamEvac-Lyo (component A), Placebo, GamEvac-Lyo (component B), GamEvac-Lyo
- Keywords
- Hemorrhagic Fever, Ebola, Ebola Virus Disease, Ebola Virus Vaccines, Hemorrhagic Fevers, Viral, GP protein, Ebola virus, Filoviridae Infections, RNA Virus Infections
- Medical subject headings
- Hemorrhagic Fever, Ebola, Hemorrhagic Fevers, Viral, Filoviridae Infections, RNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamEvac-Lyo (component A)Biological
Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component A
PlaceboOther
Placebo vaccination
GamEvac-Lyo (component B)Biological
Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component B
GamEvac-LyoBiological
Biological: GamEvac-Lyo (vaccine) vaccination, therapeutic scheme: the sequential introduction of components A and b with an interval of 21 days
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 (component A) | Experimental | a single administration of component A (VSV) of vaccine Receives: Biological: GamEvac-Lyo (component A) |
| Stage 1 (component B) | Experimental | a single administration of component B (Ad5) of vaccine Receives: Biological: GamEvac-Lyo (component B) |
| Stage 2 (Primary Group) | Experimental | 150 people who will receive the vaccine in the therapeutic scheme: the sequential introduction of components A and B with an interval of 21 days Receives: Biological: GamEvac-Lyo |
| Stage 2 (Controll Group) | Placebo comparator | 50 people who will receive placebo in the therapeutic scheme: the sequential introduction of components A (placebo) and B (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 90 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 90 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 90 days
Antibody levels against the EBOV glycoprotein GP measured by an enzyme-linked immunosorbent assay (ELISA)
Determination of antibody levels against the EBOV glycoprotein GP measured by an ELISA vs. baseline values and placebo
Measured: at days 0, 21, 42, 28 and 90
Secondary outcomes (4)
Assessment of antigen-specific cell-mediated immune response
determination of specific T-cell- mediated response to Ebola virus proteins vs. baseline values and placebo
Measured: at days 0 and 28
Neutralizing antibody levels measured by a virus-neutralization assay
Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values and placebo
Measured: at days 0 and 28
Change of the vital signs (systolic and diastolic blood pressure, heart rate, body temperature) after administration of the product
Evaluation of the product safety by assessing its impact on the vital signs (systolic and diastolic blood pressure, heart rate, body temperature) in healthy volunteers after administration of the product in comparison to placebo
Measured: through the whole study, an average of 90 days
Change of the clinical laboratory test results after administration of the product
Evaluation of the product safety by assessing its impact on the clinical laboratory test results in healthy volunteers after administration of the product in comparison with placebo
Measured: through the whole study, an average of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start3 Nov 2017
- Primary completion30 Nov 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 220 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
- Research Institute of Influenza, Sankt-Peterburg, Russian Federation
- Responsible party
- Sponsor
- Investigators
- Tatiana Zubkova, MD, PhD, Principal investigator, Research Institute of Influenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333538
- Sponsor's protocol ID
- 01-GamEvac-Lyo-2017
- Status last verified
- Aug 2018
- First submitted
- 29 Sep 2017
- Last updated
- 14 Nov 2019
- 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 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of Medicinal Product GamEvac-Lyo, Vector-Based Vaccine Against Ebola Virus Disease, Lyophilisate for Preparation of Solution for Intramuscular Injection
- ClinicalTrials.gov ID
- NCT03333538
- Acronym / sponsor ID
- 01-GamEvac-Lyo-2017
- Conditions
- Healthy Volunteers
- Keywords
- Hemorrhagic Fever, Ebola, Ebola Virus Disease, Ebola Virus Vaccines, Hemorrhagic Fevers, Viral, GP protein, Ebola virus, Filoviridae Infections, RNA Virus Infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- Research Institute of Influenza, Sankt-Peterburg, Russian Federation
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Nov 2017 (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 purpose of this study is to evaluate immunogenicity and safety of medicinal product GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease
Detailed description
This clinical trial is designed as a double blind randomized placebo-controlled study to evaluate immunogenicity of medicinal product GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease The study will consist of two stages. At the first stage in this research is planned to study the safety and tolerability of one dose of component A and B combined vaccine vector against Ebola in 20 healthy volunteers: 10 for component A and 10 to component B. In the first stage, the placebo will not be used. The duration of screening up to 10 days.
Volunteers at the first stage will receive the drug 1 time on the first day of the study. On the third day of the study (48 hours after administration of the vaccine) they will be discharged from the hospital. There will also be 1 outpatient visit on day 7 after drug administration.
After interim analysis of safety data is subject to the consent of the local ethics Committee of the Research Centre about the possibility of further studies of the drug - will be started the second phase of the study, which, along with continued security research, provides the definition of the parameters of immunogenicity of the study drug. The second phase of the study will included 200 participants, including 150 people will receive the study drug and 50 will be a control group of observation - that is, will get a placebo.
Study Schedule Visit 0 (outpatient): screening Visit 1 (inpatient): Immunization with component A/placebo (observation at the hospital for 48 hours). Local adverse reactions will be monitored during the entire observation period; on the day of immunization - local and systemic reactions should be recorded 20 minutes, 5 and 8 hours after the vaccine administration. Later, in-hospital local and systemic adverse reactions to the product will be documented during physical examinations twice a day (morning and evening) and also prior the subjects are discharged from the hospital. Adverse events will be then recorded in the "Daily Diaries" kept by the subjects during the outpatient stage.
Visit 2: Day 7 after the first vaccine administration - outpatient setting. Visit 3 (inpatient) (Day 21) Immunization with component B/placebo (observation at the hospital for 48 hours): Local adverse reactions will be monitored during the entire observation period; on the day of immunization - local and systemic reactions should be recorded 20 minutes, 5 and 8 hours after the vaccine administration. Later, in-hospital local and systemic adverse reactions to will be documented during physical examinations twice a day (morning and evening) and also before the subjects are discharged from the hospital. Adverse events will be recorded in the "Daily Diaries" kept by the subjects during the outpatient stage.
Visits #4, 5, 6 - will be held in outpatient settings on Days 28 , 42 and 90 after the vaccine administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Stage 1 (component A) | Experimental | Biological: GamEvac-Lyo (component A)a single administration of component A (VSV) of vaccine |
| Stage 1 (component B) | Experimental | Biological: GamEvac-Lyo (component B)a single administration of component B (Ad5) of vaccine |
| Stage 2 (Primary Group) | Experimental | Biological: GamEvac-Lyo150 people who will receive the vaccine in the therapeutic scheme: the sequential introduction of components A and B with an interval of 21 days |
| Stage 2 (Controll Group) | Placebo comparator | Other: Placebo50 people who will receive placebo in the therapeutic scheme: the sequential introduction of components A (placebo) and B (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 (18 listed)
- males and females within the age range from 18 to 55 years;
- written informed consent;
- subject body mass index (BMI): 18.5 ≤ BMI ≤ 30
- subject agrees to use effective contraceptive methods during the entire period of participation in the study (one of the following methods will be used: sexual abstinence; condoms (male or female with or without spermicidal agent); diaphragm or cervical cap with spermicidal agent; intrauterine device);
- absence of severe allergic diseases in the medical history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum disease)
Key exclusion criteria (22 listed)
- volunteer involvement in another study over the last 90 days
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 |
|---|---|---|
| GamEvac-Lyo (component A)Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component A | Biological | Stage 1 (component A) |
| PlaceboPlacebo vaccination | Other | Stage 2 (Controll Group) |
| GamEvac-Lyo (component B)Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component B | Biological | Stage 1 (component B) |
| GamEvac-LyoBiological: GamEvac-Lyo (vaccine) vaccination, therapeutic scheme: the sequential introduction of components A and b with an interval of 21 days | Biological | Stage 2 (Primary Group) |
Primary outcome
Number of Participants With Adverse Events
Time frame: through the whole study, an average of 90 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 90 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 90 days
Determination of Number of Participants with Solicited Local and Systemic Adverse Events
Antibody levels against the EBOV glycoprotein GP measured by an enzyme-linked immunosorbent assay (ELISA)
Time frame: at days 0, 21, 42, 28 and 90
Determination of antibody levels against the EBOV glycoprotein GP measured by an ELISA vs. baseline values and placebo
4 secondary outcomes
Assessment of antigen-specific cell-mediated immune response
Time frame: at days 0 and 28
Neutralizing antibody levels measured by a virus-neutralization assay
Time frame: at days 0 and 28
Change of the vital signs (systolic and diastolic blood pressure, heart rate, body temperature) after administration of the product
Time frame: through the whole study, an average of 90 days
Change of the clinical laboratory test results after administration of the product
Time frame: through the whole study, an average of 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Individual participant dataSharing planned: No
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Healthy Participants
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
Research Institute of Influenza
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 GamEvac-Lyo (component A), GamEvac-Lyo (component B) and GamEvac-Lyo in people with Healthy Volunteers, 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 18 inclusion and 22 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: finished, as of the sponsor's last update on 14 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants With Adverse Events (time frame: through the whole study, an average of 90 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 Nov 2019.