Healthy Volunteers Clinical Trial
Official title:
A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of Medicinal Product GamEvac-Lyo, Vector-Based Vaccine Against Ebola Virus Disease, Lyophilisate for Preparation of Solution for Intramuscular Injection
The purpose of this study is to evaluate immunogenicity and safety of medicinal product GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease
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.
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