Study of Safety and Immunogenicity of BVRS-GamVac-Combi

MERS (Middle East Respiratory Syndrome) Clinical Trial

Official title: Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac-Combi", a Combined Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers

Status Recruiting

Clinical Trial Summary

The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%.

The aim of the study is to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.

Clinical Trial Description

The study will include volunteers of both sexes, aged 18-55 years inclusive. The study will involve 268 (will receive the vaccine or placebo) healthy volunteers.

At the first stage, it is planned:

• study the safety of component 1 - 40 volunteers and 4 spares *

• study the safety of prime-boost vaccination with component 1 and component 2 with an interval of 21 days in half and full dose - 40 volunteers and 4 spares * At the second phase, it is planned to study the safety and immunogenicity of the vaccine as part of a placebo-controlled randomized trial - 188 people, of whom 138 will receive the vaccine, and 50 will make up the control group of observation - they will be given a placebo. Data from 20 volunteers from the first phase who received the drug in selected dose will be included in the analysis of safety and immunogenicity of the second phase.

• Volunteers are replaced by spares before the introduction of the drug, if the volunteer took the drug, then the replacement is not performed.

Any volunteer who received a dose of the vaccine will be considered as included in the study, the data available on it will be used in assessing the safety and tolerability of the drug. ;

Related Conditions & MeSH terms

• Coronavirus Infections
• MERS
• MERS (Middle East Respiratory Syndrome)
• Syndrome

• NCT number: NCT04128059
• Study type: Interventional
• Source: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Contact: Inna Dolzhikova, PhD
• Phone: 1933001
• Email: info@gamaleya.org
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 6, 2019
• Completion date: December 31, 2021