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Life sciences · Journal article
The Lancet. Microbe
A consensus or society position rather than new primary data.
This Series paper synthesizes evidence on TB vaccine candidates and preventive therapies up to early 2026, reporting that 18 vaccine candidates are in development with 6 in phase 3 trials, and that short-course rifamycin-containing TPT regimens show non-inferior efficacy to 6–9 months of isoniazid monotherapy with higher completion rates. The review indicates promising opportunities for TB incidence reduction but identifies gaps in efficacy data for newer preventive regimens and emphasizes dependence on implementation in high-burden settings.
Narrative review and evidence synthesis. TB vaccine candidates in clinical development and TB preventive treatment regimens; global population initiating TPT and at risk of TB.. Intervention: TB vaccine candidates (18 total, including 6 in phase 3) and short-course rifamycin-containing TPT regimens.. Compared with: 6–9 months of daily isoniazid monotherapy (for TPT); traditional BCG vaccination (for novel vaccine candidates).. Global; WHO Global Tuberculosis Report data and worldwide TPT uptake cited..
18 TB vaccine candidates in active clinical development as of June 4, 2026, including 6 in phase 3 trials (M72/AS01E, MTBVAC, VPM1002, GamTBvac, Immuvac [MIP], and BCG revaccination). Short-course rifamycin-containing TPT regimens—1 month daily isoniazid plus rifapentine, 3 months weekly isoniazid plus rifapentine, 3 months daily isoniazid plus rifampicin, or 4 months daily rifampicin—show non-inferior efficacy and higher completion rates than 6–9 months daily isoniazid monotherapy. In 2024, 5·3 million people at high risk of TB initiated TPT globally, including 3·5 million household contacts and 1·8 million people with HIV.
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Clinicians and TB programme managers should be aware that short-course rifamycin-containing regimens are now WHO-preferred options with evidence of non-inferiority and superior completion compared to traditional 6–9 month isoniazid monotherapy. The growing vaccine pipeline offers future prevention options, but near-term implementation relies on translating completed phase 3 trials into accessible programmes in high-burden settings.
A narrative review synthesizing current evidence on TB vaccine pipelines and preventive therapies, providing clinical and policy guidance rather than reporting primary efficacy data.
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Clinicians and TB programme managers should be aware that short-course rifamycin-containing regimens are now WHO-preferred options with evidence of non-inferiority and superior completion compared to traditional 6–9 month isoniazid monotherapy. The growing vaccine pipeline offers future prevention options, but near-term implementation relies on translating completed phase 3 trials into accessible programmes in high-burden settings.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Tuberculosis remains the leading cause of death from a single infectious agent globally. The WHO Global Tuberculosis Report 2025 indicates that progress towards the WHO End TB Strategy targets remains off track despite modest declines in incidence and mortality. In 2024, an estimated 10·7 million people developed tuberculosis and 1·23 million died from the disease. In this Series paper, we examine evidence published between Jan 6, 2020, and Jan 6, 2026, to provide an updated overview of tuberculosis vaccines and tuberculosis preventive treatment (TPT). As of June 4, 2026, 18 tuberculosis vaccine candidates are in active clinical development, including six in phase 3 (M72/AS01E, MTBVAC, VPM1002, GamTBvac, Immuvac [MIP], and BCG revaccination trials), representing the most diverse and advanced pipeline since the introduction of BCG in 1921. Platforms include live-attenuated mycobacterial vaccines (eg, MTBVAC), recombinant BCG-derived approaches (eg, VPM1002), protein-adjuvant subunit vaccines (eg, M72/AS01E), viral-vectored candidates (eg, AdHu5Ag85A, ChAdOx1.85A, and TB/FLU-04L), and inactivated whole-cell strategies (eg, DAR-901, RUTI, and Immuvac [MIP]). However, only a few candidates have progressed to late-stage efficacy evaluation. Short-course rifamycin-containing TPT regimens-1 month of daily isoniazid plus rifapentine, 3 months of once-weekly isoniazid plus rifapentine, 3 months of daily isoniazid plus rifampicin, and 4 months of daily rifampicin-show non-inferior efficacy and higher completion rates than 6-9 months of daily isoniazid monotherapy and are WHO-preferred options for drug-susceptible tuberculosis. In 2024, 5·3 million people at high risk of tuberculosis initiated TPT globally, including 3·5 million household contacts and 1·8 million people with HIV. For contacts of multidrug-resistant or rifampicin-resistant tuberculosis, randomised trials and pooled analyses support 6 months of daily levofloxacin to reduce incident multidrug-resistant tuberculosis. Bedaquiline-containing preventive regimens and shorter fluoroquinolone-based combinations are under clinical evaluation, but definitive phase 3 efficacy data are not yet available. The expansion of the vaccine pipeline alongside improved short-course preventive regimens offers a credible opportunity to accelerate tuberculosis incidence decline, although translation into population-level impact will depend on shown efficacy, sustained financing, reliable drug and vaccine supply, and effective implementation in high-burden settings.
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