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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhagic Fever, Ebola
• Intervention / Treatment: Procedure: blood sampling collection

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation
    • Federal state budget military educational institution of higher education "Military medical Academy named after S. M. Kirov" Ministry of defense of the Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 56 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 02-E-2015 in October-November 2015.

Description

Inclusion Criteria:

• Males and females aged 18-56 who had been earlier vaccinated with medicinal product GamEvac in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 02-E-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 in the dosages of 0.25 ml and 0.5 ml, during the study under Protocol 02-E-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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
dosages of 0.25 ml; 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 in the dosages of 0.25 ml, during the study under Protocol 02-E-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.
dosages of 0.5 ml; 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 in the dosages of 0.5 ml, during the study under Protocol 02-E-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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: - using ELISA method 24 months after the vaccination vs. baseline values	24 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 18 months after the vaccination vs. baseline values	18 months after the vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	12, 18 and 24 months after the vaccination

Collaborators and Investigators

• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Investigators: Principal Investigator: Konstantin Zhdanov, MD, PhD, Federal state budget military educational institution of higher education "Military medical Academy named after S. M. Kirov" Ministry of defense of the Russian Federation

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 25, 2017
• Study Completion (Actual): December 25, 2017

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 25, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Ebola; GP protein, Ebola virus; Ebola Virus Vaccines; Haemorrhagic Fever; Ebola Infection
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Mononegavirales Infections; Filoviridae Infections; Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral
• Other Study ID Numbers: 03 - GamEvac-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED