Open Study of the Duration of Immunity After Vaccination With GamEvac

Status Completed

Clinical Trial Summary

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 GamEvacVector-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.

Clinical Trial Description

This clinical trial is designed as an open study to evaluate the duration of immunity persistence following the administration of medicinal product GamEvac 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 Vector-Based Vaccine against Ebola Virus Disease in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 02-E-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 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. ;

Study Design

Related Conditions & MeSH terms

Hemorrhagic Fever, Ebola

Clinical Trial Details

NCT number	NCT02911428
Study type	Observational
Source	Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Contact
Status	Completed
Phase	N/A
Start date	October 2016
Completion date	December 25, 2017

View Details

See also
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Completed	`NCT02378753` - STRIVE (Sierra Leone Trial to Introduce a Vaccine Against Ebola)	Phase 2/Phase 3
Available	`NCT05067166` - Open-Label Expanded Access for Ebola-Infected Patients to Receive Human mAb Ansuvimab as Therapeutic or for HR PEP

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.