Back to resultsInternational Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi
Primary Purpose
Ebola Virus Disease, Prevention
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
GamEvac-Combi (vaccine)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Ebola Virus Disease focused on measuring Ebola Virus Disease, Hemorrhagic Fever, Ebola, Vaccines, GP protein, Ebola virus, Ebola Virus Vaccines
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- - 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.
Sites / Locations
- Centre de recherche en épidémiologie, microbiologie et de soins médicaux (CREMS) de Pastoria à Kindia
- Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Drug Group
Placebo Drug Group
Arm Description
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
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
assessment of antigen-specific cell-mediated immune response
determination of specific T-cell- mediated response to Ebola virus proteins vs. baseline values and placebo
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
Full Information
NCT ID
NCT03072030
First Posted
February 20, 2017
Last Updated
August 23, 2020
Sponsor
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Collaborators
CREMS (Centre de Recherche Epidémiologie, Microbiologie et Soins médicaux )
1. Study Identification
Unique Protocol Identification Number
NCT03072030
Brief Title
International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi
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 "
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
July 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Collaborators
CREMS (Centre de Recherche Epidémiologie, Microbiologie et Soins médicaux )
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ebola Virus Disease, Prevention
Keywords
Ebola Virus Disease, Hemorrhagic Fever, Ebola, Vaccines, GP protein, Ebola virus, Ebola Virus Vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This clinical trial is designed as a double blind randomized placebo-controlled study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Drug Group
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo Drug Group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
GamEvac-Combi (vaccine)
Intervention Description
vaccination
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
vaccination
Primary Outcome Measure Information:
Title
determination of immunity duration by ELISA method
Description
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)
Time Frame
the total Time Frame is 12 month after the vaccination
Secondary Outcome Measure Information:
Title
assessment of antigen-specific cell-mediated immune response
Description
determination of specific T-cell- mediated response to Ebola virus proteins vs. baseline values and placebo
Time Frame
on days 0 and 28
Title
determination of immunity duration in virus neutralization reaction
Description
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
Time Frame
on days 0 and 42
Other Pre-specified Outcome Measures:
Title
safety and tolerability
Description
Incidence in the healthy volunteers vital parameters changes and the occurrence of systemic and local post-vaccination reactions in comparison with placebo; reviewing its impact on the vital parameters in healthy volunteers (systolic and diastolic blood pressure, heart rate, respiration rate, body temperature) and the occurrence of systemic and local post-vaccination reactions in comparison with placebo
Time Frame
through study completion, an average of 1 year
Title
epidemiological effectiveness of vaccination
Description
2. Where possible, to evaluate epidemiological effectiveness of vaccination based on the follow-on morbidity indicators of immunized and non-immunized individuals, manifestations of the epidemiological process in time and space
Time Frame
through study completion, an average of 1 year"
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylla Ali Lathyr
Organizational Affiliation
physician administrator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marina Rusanova, MD, PhD
Organizational Affiliation
doctor of infectious department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche en épidémiologie, microbiologie et de soins médicaux (CREMS) de Pastoria à Kindia
City
Kindia
Country
Guinea
Facility Name
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi
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