International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi
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 "
2 other identifiers
interventional
2,000
2 countries
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2017
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 7, 2017
CompletedStudy Start
First participant enrolled
August 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedAugust 25, 2020
July 1, 2019
2.4 years
February 20, 2017
August 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
the total Time Frame is 12 month after the vaccination
Secondary Outcomes (2)
assessment of antigen-specific cell-mediated immune response
on days 0 and 28
determination of immunity duration in virus neutralization reaction
on days 0 and 42
Other Outcomes (2)
safety and tolerability
through study completion, an average of 1 year
epidemiological effectiveness of vaccination
through study completion, an average of 1 year"
Study Arms (2)
Active Drug Group
EXPERIMENTAL1900 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 COMPARATOR100 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
Interventions
Eligibility Criteria
You may qualify if:
- 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;
- 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
You may not qualify if:
- \- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre de recherche en épidémiologie, microbiologie et de soins médicaux (CREMS) de Pastoria à Kindia
Kindia, Guinea
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Moscow, Russia
Related Publications (1)
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.
PMID: 40207235DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylla Ali Lathyr
physician administrator
- PRINCIPAL INVESTIGATOR
Marina Rusanova, MD, PhD
doctor of infectious department
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
March 7, 2017
Study Start
August 3, 2017
Primary Completion
December 31, 2019
Study Completion
July 31, 2020
Last Updated
August 25, 2020
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share