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A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of GamEvac-Lyo

NCT03333538 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2019-11-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate immunogenicity and safety of medicinal product GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

GamEvac-Lyo (component A)

Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component A

OTHER

Placebo

Placebo vaccination

BIOLOGICAL

GamEvac-Lyo (component B)

Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component B

BIOLOGICAL

GamEvac-Lyo

Biological: GamEvac-Lyo (vaccine) vaccination, therapeutic scheme: the sequential introduction of components A and b with an interval of 21 days

Sponsors & Collaborators

  • Research Institute of Influenza, Sankt-Peterburg, Russian Federation

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Tatiana Zubkova, MD, PhD · Research Institute of Influenza

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2018-11-30
Completion
2018-12-31

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 NCT03333538 on ClinicalTrials.gov