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A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of BVRS-GamVac-Combi

2019-10-21 12:45:29 | BioPortfolio

Summary

Two-stage, open-dose, prospective, double-blind, randomized, placebo-controlled study in parallel groups

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.

Study Design

Conditions

Healthy Volunteers

Intervention

BVRS-GamVac-Combi, placebo

Location

Bessalar
Moscow
Russian Federation

Status

Not yet recruiting

Source

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

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-21T12:45:29-0400

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