Open Study of the Duration of Immunity After Vaccination With GamEvac-Combi

Brief Title

Open Study of the Duration of Immunity After Vaccination With GamEvac-Combi

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 Description

      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.
    


Study Type

Observational


Primary Outcome

duration of immunity using ELISA method

Secondary Outcome

 duration of immunity in virus neutralization reaction

Condition

Ebola Hemorrhagic Fever

Intervention

blood sampling collection

Study Arms / Comparison Groups

 the dosage of 0.25 ml
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

60

Start Date

October 2016

Completion Date

December 25, 2017

Primary Completion Date

December 25, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Males and females aged 18-56 who had been earlier vaccinated 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.

          -  Written informed consent signed by patients prior to their involvement in the study

        Exclusion Criteria:

          -  Absence of the earlier vaccination 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.

          -  Presence of a concomitant illness which could preclude obtaining a venous blood sample
             or affect the study process: (critical patient's condition, seizures, agitated state,
             blood loss and shocks of different origin).
      

Gender

All

Ages

18 Years - 56 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Konstantin Zhdanov, MD, PhD, , 

Location Countries

Russian Federation

Location Countries

Russian Federation

Administrative Informations


NCT ID

NCT02911415

Organization ID

02 - GamEvac-Combi-2016


Responsible Party

Sponsor

Study Sponsor

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation


Study Sponsor

Konstantin Zhdanov, MD, PhD, Principal Investigator, Federal State Budget-funded Military Educational Institution of Higher Education "Military Medical Academy named after S. M. Kirov" of Ministry of Defense of Russian Federation


Verification Date

September 2016