An observational study in Ebola Hemorrhagic Fever, sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 56 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-27.
Sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Observational
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.
102 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.
This study's planned enrollment of 60 is below the median of 266 across 16 observational studies indexed under Hemorrhagic Fever, Ebola.
Browse Hemorrhagic Fever, Ebola studies →Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation is the lead sponsor of 40 studies on the registry; 10 are open to participants now.
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The study will enroll up to 60 healthy volunteers of both genders aged 18-55 inclusive who had been earlier immunized with medicinal product GamEvac-Combi in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015.
Exclusion Criteria:
Blood sampling collection: 12, 18 and 24 months after the vaccination. The study will enroll up to 30 healthy volunteers of both genders aged 18-55 inclusive who had been earlier immunized with medicinal product GamEvac-Combi in the dosages of 0.25 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015.
Procedure: blood sampling collection
Blood sampling collection: 12, 18 and 24 months after the vaccination. The study will enroll up to 30 healthy volunteers of both genders aged 18-55 inclusive who had been earlier immunized with medicinal product GamEvac-Combi in the dosages of 0.5 ml, during the study under Protocol 01-COMBI-2015 in October-November 2015
Procedure: blood sampling collection
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 and clinical observation specified in this Protocol.
duration of immunity using ELISA method
To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer: - using ELISA method 12 months after the vaccination vs. baseline values
Time frame: 12 months after the vaccination
duration of immunity using ELISA method
To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer
Time frame: 18 months after the vaccination
duration of immunity using ELISA method
To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer: - using ELISA method 24 months after the vaccination vs. baseline values
Time frame: 24 months after the vaccination
duration of immunity in virus neutralization reaction
To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer
Time frame: 12 months after the vaccination vs. baseline values
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events. To assess product safety by collecting information on adverse events, development of infectious and non-infectious diseases, and on cases where vaccinated volunteers were seeking for medical care during the follow-up period
Time frame: 12, 18 and 24 months after the vaccination
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation