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International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072030
Recruitment Status : Active, not recruiting
First Posted : March 7, 2017
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
CREMS (Centre de Recherche Epidémiologie, Microbiologie et Soins médicaux )
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

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

Condition or disease Intervention/treatment Phase
Ebola Virus Disease Prevention Biological: GamEvac-Combi (vaccine) Biological: Placebo Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This clinical trial is designed as a double blind randomized placebo-controlled study
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 "
Actual Study Start Date : August 3, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: Active Drug Group
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
Biological: GamEvac-Combi (vaccine)
vaccination

Placebo Comparator: Placebo Drug Group
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
Biological: Placebo
vaccination




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. assessment of antigen-specific cell-mediated immune response [ Time Frame: on days 0 and 28 ]
    determination of specific T-cell- mediated response to Ebola virus proteins vs. baseline values and placebo

  2. determination of immunity duration in virus neutralization reaction [ Time Frame: on days 0 and 42 ]
    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


Other Outcome Measures:
  1. safety and tolerability [ Time Frame: through study completion, an average of 1 year ]
    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

  2. epidemiological effectiveness of vaccination [ Time Frame: through study completion, an average of 1 year" ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072030


Locations
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Guinea
Centre de recherche en épidémiologie, microbiologie et de soins médicaux (CREMS) de Pastoria à Kindia
Kindia, Guinea
Russian Federation
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department
Moscow, Russian Federation
Sponsors and Collaborators
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
CREMS (Centre de Recherche Epidémiologie, Microbiologie et Soins médicaux )
Investigators
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Principal Investigator: Sylla Ali Lathyr physician administrator
Principal Investigator: Marina Rusanova, MD, PhD doctor of infectious department

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Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
ClinicalTrials.gov Identifier: NCT03072030    
Other Study ID Numbers: 01 - GamEvac-Combi-2016
http://grls.rosminzdrav.ru ( Registry Identifier: the Ministry of Health of the Russian Federation )
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation:
Ebola Virus Disease
Hemorrhagic Fever, Ebola
Vaccines
GP protein, Ebola virus
Ebola Virus Vaccines
Additional relevant MeSH terms:
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Hemorrhagic Fever, Ebola
Virus Diseases
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs