Ebola Hemorrhagic Fever Clinical Trial
Official title:
Open Study of the Duration of Immunity After Vaccination With Medicinal Product GamEvac-Combi - Combined Vector-Based Vaccine Against Ebola Virus Disease, 0.5 ml+0.5 ml/Dose
The purpose of this study is to evaluate the post-vaccination immune status at different time points in subjects immunized against Ebola Virus Disease; to select an optimal regimen of product administration; and, to assess safety of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose, following the immunization with a half (0.25 ml+0.25 ml/dose) and full (0.5 ml+0.5 ml/dose) therapeutic doses.
This clinical trial is designed as an open study to evaluate the duration of immunity
persistence following the administration of medicinal product GamEvac-Combi - Combined
Vector-Based Vaccine against Ebola Virus Disease.
It is an observational study; no interventions are planned in the course of common clinical
practices during the study period; investigated therapeutic agents or special methods of
examination will not be used in the study, except the blood sampling procedure specified in
this Protocol. Only those patients who have signed the information consent form for
participation in the study and have been informed by physician on the objectives and methods
of this project will be involved in the study.
The study consists of a single stage which is designed as a follow-up period to observe
volunteers vaccinated in the course of evaluation of safety, reactogenic properties and
immunogenicity of product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus
Disease in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 01-COMBI-2015
in October-November 2015. Vaccination will not be made within the present study. Screening of
volunteers is not required: the study will involve as many of the volunteers as possible (but
not more than 60 subjects) who had been immunized earlier with GamEvac-Combi - Combined
Vector-Based Vaccine against Ebola Virus Disease, provided that they have no medical
contraindications for blood sampling.
Study Schedule Visit 1 (outpatient): the goal of this visit is to assess whether a patient
meets the inclusion/exclusion criteria. All procedures should be carried out upon receipt of
the informed consent form signed by patient. The visit will be held 12 months after the
vaccination.
Visit 2 (outpatient): 18 months after the vaccination. Visit 3 (outpatient): 24 months after
the vaccination. The duration of immunity persistence following product administration will
be assessed in healthy volunteers based on the measurements of specific antibody titers.
- by ELISA method 12, 18 and 24 months after the vaccination vs. baseline values;
- in virus neutralization reaction 12 months after the vaccination vs. baseline values.
;
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