NCT04130594

Study of Safety and Immunogenicity of BVRS-GamVac

Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac", a 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: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 adenoviral-based vaccine against MERS - BVRS-GamVac.

Detailed description

Two-stage, open-dose, prospective, double-blind, randomized, placebo-controlled study in parallel groups The study will include volunteers of both sexes, aged 18-55 years inclusive. The study will involve 162 (will receive the study drug or placebo) healthy volunteers, of which the first stage, it is planned to vaccinate 40 person with the studied drug (at the same time, the participation of 8 spares \*), at the second phase - 122 people, of whom 88 will receive the study drug, and 34 will make up the control group of observation - they will be given a placebo drug. \* Volunteers are replaced by spares before the introduction of the drug, if the volunteer took the drug, then its replacement is not performed. Any volunteer who received a dose of the test drug 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.

Conditions

• MERS (Middle East Respiratory Syndrome)
• MERS

Interventions

Type	Name	Description
BIOLOGICAL	BVRS-GamVac	a vector vaccine for the prevention of the Middle East respiratory syndrome, lyophilisate for the preparation of a solution for intramuscular administration
OTHER	placebo	placebo

Timeline

• Start date: 2019-11-07
• Primary completion: 2021-07-01
• Completion: 2021-07-31
• First posted: 2019-10-17
• Last updated: 2021-01-14

Locations

1 site across 1 country: Russia