A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of GamEvac-Lyo
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Intervention name(s): GamEvac-Lyo (component A); Placebo; GamEvac-Lyo (component B); GamEvac-Lyo
Intervention type(s): Biological; Other; Biological; Biological
Intervention description(s): Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component A; Placebo vaccination; Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component B; Biological: GamEvac-Lyo (vaccine) vaccination, therapeutic scheme: the sequential introduction of components A and b with an interval of 21 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hemorrhagic Fever, Ebola; Ebola Virus Disease; Ebola Virus Vaccines; Hemorrhagic Fevers, Viral; GP protein, Ebola virus; Filoviridae Infections; RNA Virus Infections