NCT02911428

Open Study of the Duration of Immunity After Vaccination With GamEvac

Open Study of the Duration of Immunity After Vaccination With Medicinal Product GamEvac-Vector-Based Vaccine Against Ebola Virus Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years – 56 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hemorrhagic Fever, Ebola

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-12-25
• Completion: 2017-12-25
• First posted: 2016-09-22
• Last updated: 2017-12-27

Locations

1 site across 1 country: Russia