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

Healthy Volunteers Clinical Trial

Official title: A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of Medicinal Product GamEvac-Lyo, Vector-Based Vaccine Against Ebola Virus Disease, Lyophilisate for Preparation of Solution for Intramuscular Injection

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

This clinical trial is designed as a double blind randomized placebo-controlled study to evaluate immunogenicity of medicinal product GamEvac-Lyo- Vector-Based Vaccine against Ebola Virus Disease The study will consist of two stages. At the first stage in this research is planned to study the safety and tolerability of one dose of component A and B combined vaccine vector against Ebola in 20 healthy volunteers: 10 for component A and 10 to component B. In the first stage, the placebo will not be used. The duration of screening up to 10 days.

Volunteers at the first stage will receive the drug 1 time on the first day of the study. On the third day of the study (48 hours after administration of the vaccine) they will be discharged from the hospital. There will also be 1 outpatient visit on day 7 after drug administration.

After interim analysis of safety data is subject to the consent of the local ethics Committee of the Research Centre about the possibility of further studies of the drug - will be started the second phase of the study, which, along with continued security research, provides the definition of the parameters of immunogenicity of the study drug. The second phase of the study will included 200 participants, including 150 people will receive the study drug and 50 will be a control group of observation - that is, will get a placebo.

Study Schedule Visit 0 (outpatient): screening Visit 1 (inpatient): Immunization with component A/placebo (observation at the hospital for 48 hours). Local adverse reactions will be monitored during the entire observation period; on the day of immunization - local and systemic reactions should be recorded 20 minutes, 5 and 8 hours after the vaccine administration. Later, in-hospital local and systemic adverse reactions to the product will be documented during physical examinations twice a day (morning and evening) and also prior the subjects are discharged from the hospital. Adverse events will be then recorded in the "Daily Diaries" kept by the subjects during the outpatient stage.

Visit 2: Day 7 after the first vaccine administration - outpatient setting. Visit 3 (inpatient) (Day 21) Immunization with component B/placebo (observation at the hospital for 48 hours): Local adverse reactions will be monitored during the entire observation period; on the day of immunization - local and systemic reactions should be recorded 20 minutes, 5 and 8 hours after the vaccine administration. Later, in-hospital local and systemic adverse reactions to will be documented during physical examinations twice a day (morning and evening) and also before the subjects are discharged from the hospital. Adverse events will be recorded in the "Daily Diaries" kept by the subjects during the outpatient stage.

Visits #4, 5, 6 - will be held in outpatient settings on Days 28 , 42 and 90 after the vaccine administration. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT03333538
• Study type: Interventional
• Source: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 3, 2017
• Completion date: December 31, 2018