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Open Study of the Duration of Immunity After Vaccination With GamEvac

NCT02911428 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2017-12-27

No results posted yet for this study

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.

Conditions

  • Hemorrhagic Fever, Ebola

Interventions

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • 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

Eligibility

Min Age
18 Years
Max Age
56 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-12-25
Completion
2017-12-25

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02911428 on ClinicalTrials.gov