Clinical Trial: Open Study of the Duration of Immunity After Vaccination With GamEvac-Combi
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
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
Brief 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 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.
Detailed Summary:
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.
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
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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- duration of immunity in virus neutralization reaction [ Time Frame: 12 months after the vaccination vs. baseline values ]To evaluate the duration of immunity persistence following the product administration in healthy volunteers by measuring the specific antibody titer
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 12, 18 and 24 months after the vaccination ]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
Original Secondary Outcome: Same as current
Information By: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federat
Dates:
Date Received: September 14, 2016
Date Started: October 2016
Date Completion: December 2017
Last Updated: October 19, 2016
Last Verified: September 2016
