drugset / Trial / NCT03255278
Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis.
Phase 1
Completed
60 enrolled
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
RandomizedSingle-groupSingle-blindPrevention
Summary
The study is aimed to evaluate the safety and immunogenicity of the medicinal product "GamTBvac" - a recombinant subunit vaccine against the tuberculosis. The study is designed as a comparative placebo-controlled study with a two-fold increase of an applied dose among healthy volunteers aged 18-49 years.
Timeline
- Start
- 2017-01-15
- Primary completion
- 2017-12-13
- Completion
- 2017-12-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GamTBvac | Vaccine | 0.25 unknown | Subcutaneous |
| Subject | GamTBvac | Vaccine | 0.5 unknown | Subcutaneous |
| Subject | GamTBvac | Vaccine | 1 unknown | Subcutaneous |