drugset / Trial / NCT03878004
Phase II Clinical Trial of Safety and Immunogenicity of Recombinant Subunit Tuberculosis Vaccine GamTBvac
Phase 2
Completed
180 enrolled
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
contract research organization Cromos Pharma · collabcontract research organization K-Research · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This is a double-blind, randomized (in 3:1 ratio -vaccine : placebo) study to assess the safety, reactogenicity and immunogenicity in healthy, BCG vaccinated adults.
Timeline
- Start
- 2018-12-01
- Primary completion
- 2019-12-31
- Completion
- 2020-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GamTBvac | Vaccine | 5.35 mg | Subcutaneous |
Indications
No indication recorded.