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Tuberculosis Integrated Model-Based Evidence and Recommendations (TIMBER) for robust TB vaccine decision-making by National Immunization Technical Advisory Groups (NITAGs) in Africa.

The TIMBER study is a multi-country research study aimed at strengthening the use of model-based evidence to support national decision-making on the introduction of new TB vaccines in Africa. The study brings together National Immunization Technical Advisory Groups (NITAGs), policymakers, researchers, modellers and other stakeholders in South Africa, Kenya and The Gambia to co-create models and explore how modelling can be used effectively within the WHO Evidence-to-Recommendation process. TIMBER will generate country-specific evidence, strengthen capacity for using modelling in vaccine policy decisions, and develop practical approaches to support timely, evidence-informed introduction of new TB vaccines.

Facing up to reality? What to do if M72/AS01E doses are limited

The Ph3 trial for the vaccine candidate M72/AS01E is underway, and, assuming a positive result, could be licensed by 2030. Modelling suggested a large potential impact from introducing M72/AS01E but assumed an unconstrained dose supply. However, at least initially, it is likely that M72/AS01E will be supply-constrained. We estimated the effect of decisions surrounding the allocation of constrained doses on the potential global impact of M72/AS01E

The potential health and economic impact of introducing the vaccine candidate VPM1002 to prevent tuberculosis disease in low- and middle-income countries

This study estimates the potential health and economic impact of introducing the TB vaccine candidate VPM1002 in 79 low- and middle- income countries. It models routine vaccination and vaccination campaigns, estimating TB cases and deaths averted and the cost-effectiveness of different introduction scenarios. It provides evidence for decisions about the potential future introduction and scale-up of VPM1002

The potential impact of novel tuberculosis vaccine introduction on economic growth in low- and middle-income countries

Estimates the potential economic impact of introducing novel TB vaccines in 105 low- and middle- income countries. It compares ifnant and adolescents/ adult vaccination scenarios and models their effects on TB- related mortality, morbidity, healthcare costs and GDP. Finding support decision making on the future development and introduciton of novel TB vaccines

Epidemiologic study to assess the IGRA positivity in populations with a high TB

Tuberculosis (TB) vaccine efficacy trials evaluating prevention of disease must be feasible in size and duration and would ideally take place at clinical trial sites that enroll from communities with the highest incidence rates. In preparation for the Phase 3 trial of the investigational M72/AS01E-4 vaccine, we conducted a multi-country study, using interferon gamma release assay (IGRA) positivity as a proxy for expected incidence of TB. In addition to the above objects, the results from this study could help in in new vaccine introduction to identfy TB hotspot areas.
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