Tuberculosis (TB), caused by Mycobacterium tuberculosis (MTB), is one of the leading infectious causes of adult mortality worldwide. The Bacillus Calmette-Guérin (BCG) vaccine is currently the only approved vaccine for TB prevention, but its protective efficacy against adult pulmonary TB is limited, and it lacks effective protection against primary or latent TB infection. There is an urgent need to develop more effective preventive TB vaccines. Currently, preventive TB vaccines under clinical investigation globally include live attenuated vaccines, recombinant subunit vaccines, viral vector vaccines, and mRNA vaccines. This article reviews and summarizes recent progress in the clinical development of preventive TB vaccines, analyzing and comparing their safety, immunogenicity, and protective efficacy. It also explores novel strategies for next-generation TB vaccine development, aiming to provide insights and directions for future research.
Keywords: clinical trials; immunogenicity; safety; tuberculosis vaccine.