How close are we to a new, effective tuberculosis vaccine? Recent advances in the field

Fourteen candidate TB vaccines are in clinical development, including eight in phase 2b–3 trials, although there is a paucity of new candidates advancing from preclinical testing. Live mycobacterial vaccines, including recombinant <italic>Mycobacterium bovis</italic> BCG and live-attenuated <italic>Mycobacterium tuberculosis</italic> candidates, are entering prevention of disease efficacy trials in infants and adolescents/adults. Several candidates are in nontraditional efficacy trials to prevent <italic>M. tuberculosis</italic> infection, treatment failure or recurrent disease. The most promising protein-subunit vaccine, M72/AS01_E, is expected to enter a large, multicountry, licensure trial in adolescents/adults, including PLHIV and those with/without prior <italic>M. tuberculosis</italic> sensitisation. Findings are expected by 2028. Efforts to discover immune correlates of vaccine-mediated protection are ongoing. Accelerated global TB vaccine advocacy, community sensitisation to reduce vaccine hesitancy, modelling of impact and development of the investment case, evidence considerations for policy and a framework for country-level introduction will be critical to drive demand, release funding and promote uptake of a new, effective TB vaccine. <bold>Cite as:</bold> Luabeya AKK, Tameris M, Shenje J, <italic>et al.</italic> How close are we to a new, effective tuberculosis vaccine? Recent advances in the field. <italic>In:</italic> García-Basteiro AL, Öner Eyüboğlu F, Rangaka MX, eds. The Challenge of Tuberculosis in the 21st Century (ERS Monograph). Sheffield, European Respiratory Society, 2023; pp. 164–177 [<ext-link>https://doi.org/10.1183/2312508X.10024922</ext-link>].