Dagnew, A.F., et al. Design and feasibility considerations for a phase 3 efficacy trial of the M72/AS01E-4 tuberculosis vaccine. Vaccine, 2026 Jul 11, 85:128690. PMID: 42119392
This paper presents the design and feasibility considerations for a phase 3 efficacy trial of the M72/AS01E-4 tuberculosis vaccine, which incorporates the AS01 adjuvant system. The primary focus is on evaluating vaccine efficacy in IGRA-positive, HIV-negative adults to highlight the strategic enrichment of high-risk populations for efficient detection of protective effects. The study also emphasizes safety and immunogenicity across diverse groups. Its distinctiveness lies in the extensive use of simulation modeling to optimize trial parameters, balancing statistical power, sample size, and timeline, thus advancing TB vaccine development in a resource-efficient manner. This work is critical as it provides a rigorous blueprint for testing adjuvanted TB vaccines like M72/AS01E, highlighting the importance of tailored trial designs that leverage adjuvant-induced immune responses to meet regulatory and public health goals amid ongoing global TB challenges.
The document describes a comprehensive phase 3 clinical trial protocol for the M72/AS01E-4 tuberculosis vaccine, including detailed trial design, objectives, statistical modeling, simulations, and projected outcomes. It references previous trial phases and provides data on trial simulations, sample sizes, event counts, and immunogenicity and safety assessments, indicating that it is based on extensive empirical and modeled data to support the trial’s design and objectives.
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