Development of tuberculosis vaccines in clinical trials: Current status

Tuberculosis (TB) is an important infectious disease worldwide. Currently, Bacillus Calmette-Guérin (BCG) remains the only TB vaccine licensed for human use. This TB vaccine is effective in protecting children against severe military TB but offers variable protective efficacy in adults. Therefore, new vaccines against TB are needed to overcome this serious disease. At present, around 14 TB vaccine candidates are in different phases of clinical trials. These TB vaccines in clinical evaluation can be classified into two groups including preventive pre- and post-exposure vaccines: subunit vaccines (attenuated viral vectors or adjuvanted fusion proteins), and whole-cell vaccines (genetically attenuated Mycobacterium tuberculosis (M. tb), recombinant BCG, killed M. tb or M. vaccae). Although, over the last two decades a great progress in the search for a more effective TB vaccine has been demonstrated there is still no replacement for the licensed BCG vaccine. This article summarizes the current status of TB vaccine development and identifies crucial gaps of research for the development of an effective TB vaccine in all age groups.