Open Study of the Duration of Immunity After Vaccination With GamEvac
1 other identifier
observational
60
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2016
CompletedFirst Posted
Study publicly available on registry
September 22, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2017
CompletedDecember 27, 2017
September 1, 2016
1.2 years
September 14, 2016
December 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 18 months after the vaccination vs. baseline values
18 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
Secondary Outcomes (2)
duration of immunity in virus neutralization reaction
12 months after the vaccination vs. baseline values
Incidence of Treatment-Emergent Adverse Events
12, 18 and 24 months after the vaccination
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal state budget military educational institution of higher education "Military medical Academy named after S. M. Kirov" Ministry of defense of the Russian Federation
Saint Petersburg, Russia
Biospecimen
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2016
First Posted
September 22, 2016
Study Start
October 1, 2016
Primary Completion
December 25, 2017
Study Completion
December 25, 2017
Last Updated
December 27, 2017
Record last verified: 2016-09