Ebola Virus DiseasePhase 4NCT03072030
International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi
A Phase 4 study testing GamEvac-Combi (vaccine) in people with Ebola Virus Disease and Prevention, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate immunogenicity, epidemiological efficacy and safety of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease, Prevention
- What is being tested?
- GamEvac-Combi (vaccine)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Aug 2017to 31 Jul 2020
- Phase
- Phase 4
- 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
- Males and females within the age range from 18 to 60 years;
- written informed consent;
- absence of acute infectious diseases/relapses of chronic diseases at the time of vaccine administration and 7 days prior to the vaccination;
- absence of severe allergic diseases in the medical history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum disease)
- no serious post-vaccination complications in patient's history following the earlier administration of immunobiological products
- negative blood or urine test for pregnancy (for child-bearing age females) not more than 24 hours prior to the administration of the first dose of investigated product;
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- absence of concomitant illnesses, especially dangerous or endemic for a particular region, proved by laboratory and/or clinical methods (malaria, yellow fever, Denge fever, Ebola or Marburg virus disease, poliomyelitis).
- negative results of HIV, hepatitis B and C and syphilis tests.
- adequate contraception for females and males of reproductive age.
- negative results of urine test for narcotic drug residues;
- negative result of breath alcohol test (in the expired air sample)
- absence of haematological malignancies
- absence of malignant neoplasms
Who cannot join
- - volunteer involvement in another study over the last 90 days;
- any immunization with vaccine over the last 30 days;
- symptoms of acute respiratory diseases within the last 7 days;
- administration of immunoglobulins or other blood products; taking immunosuppressive medications and/or immunomodulating agents over the last 3 months;
- pregnancy or breast feeding;
- exacerbation of allergic diseases, previous history of anaphylactic reactions or angioneurotic edema;
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- previous history of hypersensitivity or allergic reactions to the administration of any vaccines;
- allergic reactions to the vaccine components;
- presence of a concomitant illness which might affect the evaluation of study results: active tuberculosis form, chronic liver and kidney diseases, serious thyroid dysfunction or other endocrine disorders (diabetes mellitus), severe hematopoietic diseases, epilepsy and other CNS disorders, myocardial infarction in the medical history, myocarditis, endocarditis, pericarditis, ischemic heat disease and other illnesses which, in opinion of the investigator, make patient ineligible for study enrollment or may affect the course of the study.
- blood donation (450 ml or more of blood or plasma) less than 2 months prior the study commencement date.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Guinea1 site
Centre de recherche en épidémiologie, microbiologie et de soins médicaux (CREMS) de Pastoria à Kindia
Kindia
Russia1 site
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Moscow
About this study
Official title: 01 - GamEvac-Combi-2016 " International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi - Combined Vector-Based Vaccine Against Ebola Virus Disease, 0.5 ml+0.5 ml/Dose "
The purpose of this study is to evaluate immunogenicity, epidemiological efficacy and safety of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose
Read the detailed description
This clinical trial is designed as a double blind randomized placebo-controlled study to evaluate immunogenicity of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose.
The study includes three periods: screening, administration of the investigated product and follow-up. Vaccine will be administered to groups of volunteers (each group will include not more than 40 volunteers at a time; a new group of volunteers cannot be hospitalized before the earlier vaccinated volunteers are discharged from the hospital. In total, 8 visits will be held, including a screening visit; two of the visits will take place during the inpatient stage and six - during the outpatient observation.
Study design in the both facilities will be the same for all volunteers, except that the biomaterial collected for immunogenicity evaluation from volunteers included in the study in the Russian Federation will be delivered directly to the testing laboratory; biomaterial from volunteers included in the study in the Republic of Guinea will undergo primary specimen processing, be frozen and stored under the assigned temperature conditions in the research center and, as biomaterial is accumulated, it will be transported in a fridge to the study site.
In addition, laboratory tests for such concomitant infectious diseases, as yellow fever, Denge fever, Ebola and Marburg virus diseases will be carried out for epidemiological indications (i.e. in the endemic regions if disease cases are reported).
- Conditions
- Ebola Virus Disease, Prevention
- Being tested
- GamEvac-Combi (vaccine), Placebo
- Keywords
- Ebola Virus Disease, Hemorrhagic Fever, Ebola, Vaccines, GP protein, Ebola virus, Ebola Virus Vaccines
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamEvac-Combi (vaccine)Biological
vaccination
PlaceboBiological
vaccination
| Study group | Role | What they receive |
|---|---|---|
| Active Drug Group | Experimental | 1900 volunteers will be immunized with vaccine GamEvac-Combi They will receive product twice according to the following dosing regimen: on Day 1 (component A) and Day 21 of the study (component B) in the dose of 0.5 ml Receives: Biological: GamEvac-Combi (vaccine) |
| Placebo Drug Group | Placebo comparator | 100 volunteers will be immunized with placebo They will receive product twice according to the following dosing regimen: on Day 1 (placebo - component A) and Day 21 of the study (placebo- component B) in the dose of 0.5 ml Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of immunity duration by ELISA method
immunity duration determination by ELISA method includes time points in which the assessment of the immunity response (antibody titer) should be provided (21, 28, 42 days and 3, 6, 12 months after the vaccination respectively)
Measured: the total Time Frame is 12 month after the vaccination
Secondary outcomes (2)
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: on days 0 and 28
determination of immunity duration in virus neutralization reaction
Determination of the immunity duration will be provided by the assessment of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values and placebo
Measured: on days 0 and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start3 Aug 2017
- Primary completion31 Dec 2019
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ebola Virus DiseaseStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This clinical trial is designed as a double blind randomized placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,000 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
- CREMS (Centre de Recherche Epidémiologie, Microbiologie et Soins médicaux )
- Responsible party
- Sponsor
- Investigators
- Sylla Ali Lathyr, Principal investigator, physician administratorMarina Rusanova, MD, PhD, Principal investigator, doctor of infectious department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072030
- Sponsor's protocol ID
- 01 - GamEvac-Combi-2016
- Other IDs
- http://grls.rosminzdrav.ru
- Status last verified
- Jul 2019
- First submitted
- 20 Feb 2017
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Logunov DY, Dolzhikova IV, Boiro MY, Kovyrshina AV, Dzharullaeva AS, Erokhova AS, Grousova DM, Tukhvatulin AI, Izhaeva FM, Simakova YV, Ordzhonikidze MK, Lubenets NL, Zubkova OV, Scheblyakov DV, Esmagambetov IB, Shmarov MM, Semikhin AS, Tukhvatulina NM, Shcherbinin DN, Tutykhina IL, Prokhorov GS, Khovaev AA, Demidova TN, Malishev NA, Merkulova LN, Voronina OL, Fedyakina IT, Kisteneva LB, Kolobukhina LV, Mishin DV, Elakov AL, Ermolova EI, Krasnoslobodtsev KG, Larichev VF, Kruzhkova IS, Burmistrov EM, Sheremet AB, Tokarskaya EA, Gromov AV, Reshetnikov DA, Fisun AI, Kotiv BN, Ovchinnikov DV, Ivchenko EV, Zhdanov KV, Zakharenko SM, Solovev AN, Ivanov AM, Sukachev VS, Gudkov RV, Maltsev OV, Gabdrakhmanov IA, Barsukov AV, Vashchenkov VV, Demianenko NI, Ignatev SB, Asiamov KV, Kirichenko NN, Liubimov AV, Volkov II, Kriukov EV, Bazarnov NK, Kolodiazhnaia VA, Kolomoets EV, Syromyatnikova SI, Chifanov DE, Andrus AF, Kutaev DA, Borisevich SV, Naroditsky BS, Gintsburg AL. Safety and immunogenicity of GamEvac-Combi, a heterologous rVSV- and rAd5-vectored Ebola vaccine: a randomized controlled multicenter clinical trial in the Republic of Guinea and Russia. Front Immunol. 2025 Mar 20;16:1487039. doi: 10.3389/fimmu.2025.1487039. eCollection 2025.
PubMed 40207235
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 01 - GamEvac-Combi-2016 " International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi - Combined Vector-Based Vaccine Against Ebola Virus Disease, 0.5 ml+0.5 ml/Dose "
- ClinicalTrials.gov ID
- NCT03072030
- Acronym / sponsor ID
- 01 - GamEvac-Combi-2016
- Conditions
- Ebola Virus Disease, Prevention
- Keywords
- Ebola Virus Disease, Hemorrhagic Fever, Ebola, Vaccines, GP protein, Ebola virus, Ebola Virus Vaccines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- CREMS (Centre de Recherche Epidémiologie, Microbiologie et Soins médicaux )
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 7 Mar 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, epidemiological efficacy and safety of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose
Detailed description
This clinical trial is designed as a double blind randomized placebo-controlled study to evaluate immunogenicity of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose.
The study includes three periods: screening, administration of the investigated product and follow-up. Vaccine will be administered to groups of volunteers (each group will include not more than 40 volunteers at a time; a new group of volunteers cannot be hospitalized before the earlier vaccinated volunteers are discharged from the hospital. In total, 8 visits will be held, including a screening visit; two of the visits will take place during the inpatient stage and six - during the outpatient observation.
Study design in the both facilities will be the same for all volunteers, except that the biomaterial collected for immunogenicity evaluation from volunteers included in the study in the Russian Federation will be delivered directly to the testing laboratory; biomaterial from volunteers included in the study in the Republic of Guinea will undergo primary specimen processing, be frozen and stored under the assigned temperature conditions in the research center and, as biomaterial is accumulated, it will be transported in a fridge to the study site.
In addition, laboratory tests for such concomitant infectious diseases, as yellow fever, Denge fever, Ebola and Marburg virus diseases will be carried out for epidemiological indications (i.e. in the endemic regions if disease cases are reported).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This clinical trial is designed as a double blind randomized placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Active Drug Group | Experimental | Biological: GamEvac-Combi (vaccine)1900 volunteers will be immunized with vaccine GamEvac-Combi They will receive product twice according to the following dosing regimen: on Day 1 (component A) and Day 21 of the study (component B) in the dose of 0.5 ml |
| Placebo Drug Group | Placebo comparator | Biological: Placebo100 volunteers will be immunized with placebo They will receive product twice according to the following dosing regimen: on Day 1 (placebo - component A) and Day 21 of the study (placebo- component B) in the dose of 0.5 ml |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Males and females within the age range from 18 to 60 years;
- written informed consent;
- absence of acute infectious diseases/relapses of chronic diseases at the time of vaccine administration and 7 days prior to the vaccination;
- absence of severe allergic diseases in the medical history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum disease)
- no serious post-vaccination complications in patient's history following the earlier administration of immunobiological products
Key exclusion criteria (10 listed)
- - volunteer involvement in another study over the last 90 days;
- any immunization with vaccine over the last 30 days;
- symptoms of acute respiratory diseases within the last 7 days;
- administration of immunoglobulins or other blood products; taking immunosuppressive medications and/or immunomodulating agents over the last 3 months;
- pregnancy or breast feeding;
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-Combi (vaccine)vaccination | Biological | Active Drug Group |
| Placebovaccination | Biological | Placebo Drug Group |
Primary outcome
determination of immunity duration by ELISA method
Time frame: the total Time Frame is 12 month after the vaccination
immunity duration determination by ELISA method includes time points in which the assessment of the immunity response (antibody titer) should be provided (21, 28, 42 days and 3, 6, 12 months after the vaccination respectively)
2 secondary outcomes
assessment of antigen-specific cell-mediated immune response
Time frame: on days 0 and 28
determination of immunity duration in virus neutralization reaction
Time frame: on days 0 and 42
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 25 Aug 2020.
- Derived from this study: PubMed 40207235Logunov DY, Dolzhikova IV, Boiro MY, Kovyrshina AV, Dzharullaeva AS, Erokhova AS, Grousova DM, Tukhvatulin AI, Izhaeva FM, Simakova YV, Ordzhonikidze MK, Lubenets NL, Zubkova OV, Scheblyakov DV, Esmagambetov IB, Shmarov MM, Semikhin AS, Tukhvatulina NM, Shcherbinin DN, Tutykhina IL, Prokhorov GS, Khovaev AA, Demidova TN, Malishev NA, Merkulova LN, Voronina OL, Fedyakina IT, Kisteneva LB, Kolobukhina LV, Mishin DV, Elakov AL, Ermolova EI, Krasnoslobodtsev KG, Larichev VF, Kruzhkova IS, Burmistrov EM, Sheremet AB, Tokarskaya EA, Gromov AV, Reshetnikov DA, Fisun AI, Kotiv BN, Ovchinnikov DV, Ivchenko EV, Zhdanov KV, Zakharenko SM, Solovev AN, Ivanov AM, Sukachev VS, Gudkov RV, Maltsev OV, Gabdrakhmanov IA, Barsukov AV, Vashchenkov VV, Demianenko NI, Ignatev SB, Asiamov KV, Kirichenko NN, Liubimov AV, Volkov II, Kriukov EV, Bazarnov NK, Kolodiazhnaia VA, Kolomoets EV, Syromyatnikova SI, Chifanov DE, Andrus AF, Kutaev DA, Borisevich SV, Naroditsky BS, Gintsburg AL. Safety and immunogenicity of GamEvac-Combi, a heterologous rVSV- and rAd5-vectored Ebola vaccine: a randomized controlled multicenter clinical trial in the Republic of Guinea and Russia. Front Immunol. 2025 Mar 20;16:1487039. doi: 10.3389/fimmu.2025.1487039. eCollection 2025.
- 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.
Sylla Ali Lathyr principal investigator
physician administrator
Marina Rusanova, MD, PhD principal investigator
doctor of infectious department
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GamEvac-Combi (vaccine) in people with Ebola Virus Disease and Prevention, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 2 sites in 2 countries.
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 10 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guinea, 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
determination of immunity duration by ELISA method (time frame: the total Time Frame is 12 month after the vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03072030, which also lists 1 linked publication.
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 25 Aug 2020.