BACKGROUND:
Tuberculosis remains a major global public health challenge, causing over 10 million new cases annually, particularly in low socioeconomic settings¹,². The limited and waning protection conferred by BCG highlights the urgent need for new vaccines, particularly those targeting adolescents and adults, to effectively interrupt transmission.²,³

METHODS:
Scoping review conducted in accordance with JBI and PRISMA ScR guidelines. Searches performed in PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and Google Scholar to identify clinical trials reporting safety, immunogenicity, and efficacy data for tuberculosis vaccines currently in Phase III trials.

RESULTS:
Serious adverse events were rare and generally unrelated to vaccination. Laboratory abnormalities were infrequent and self limited. Local reactions were the most commonly reported adverse events. Live vaccines (MTBVAC and VPM1002) were less reactogenic than BCG at lower doses but showed slightly increased reactogenicity at higher doses. All candidates demonstrated immunogenicity, inducing polyfunctional Th1 type cellular responses. Live attenuated vaccines elicited immune responses comparable to BCG and, at higher doses, even stronger responses. In a cohort exceeding 23,000 individuals in a high burden setting, recipients of the inactivated vaccine Immuvac showed a reduced incidence of pulmonary tuberculosis. Recombinant subunit vaccines (GamTBvac and M72/AS01E) generated robust and sustained cellular and humoral responses, with boosting observed after the second dose. Among the evaluated candidates, M72/AS01E is the only one with published efficacy data, demonstrating approximately 50% protection over 36 months of follow up.

CONCLUSIONS:
Late stage tuberculosis vaccine candidates encompass a range of platforms and consistently demonstrate favorable safety and immunogenicity profiles. Ongoing Phase III trials are essential to confirm protective efficacy. When combined with data on cost, manufacturing capacity, and implementation feasibility, these findings will inform national decision making regarding vaccine adoption, supporting strategies tailored to epidemiological patterns and health system capacity, and ultimately contributing to reductions in disease burden and health inequities.