Russian tuberculosis vaccine enters Phase 3 trials

Gintsburg told TASS that the vaccine is intended to prevent tuberculosis infection itself, rather than simply reducing the severity of the disease. He said the Phase 3 clinical trials have been completed and that statistical analysis of data from several thousand participants is currently underway, with preliminary results described as promising.

Before a drug or vaccine can be registered, it typically undergoes three phases of clinical trials. Phase 1 primarily assesses safety in humans and usually involves 20 to 80 healthy volunteers. Phase 2 generally includes 100 to 300 people with the condition targeted by the treatment to further assess its safety and effectiveness.

In Phase 3, trials expand to several thousand participants of different ages and sexes to confirm the treatment’s benefits and safety on a broader scale. Phase 4 takes place after regulatory approval and market introduction, focusing on long-term safety monitoring and assessing potential interactions with other medicines.