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Advancing evidence-informed in-country decision-making for new TB vaccine introduction: A responsive and integrated vaccine modelling approach from India

As new TB vaccines move into late-stage development, it is imperative for high-burden countries like India to ensure timely and effective evidence-generation to inform decision-making and accelerate vaccine development and introduction. To enable this, an in-country vaccine mathematical modelling effort has been initiated in India.

Part of Change 2.0

Actionable market intelligence, including vaccine demand forecast/scenarios, generated to strategically guide manufacturers and partners in their planning for introduction in high burden countries. The objectives include: 1. Strategic assessment of appropriate market-shaping interventions, 2.Stakeholder and decision process mapping , 3.Demand dynamics understanding and realistic market forecast development, 4. Commercialization strategy support for lead candidate(s).

Prep4TBVax

New TB vaccines are likely to be crucial in addressing the ongoing TB pandemic. With multiple promising vaccine candidates in the pipeline and the earliest availability of a candidate expected by 2028, it is of outmost importance that once available, the vaccine can be implemented rapidly and effectively. Limited research has looked at the delivery strategies available to provide a new TB vaccine to beneficiaries and therefore, this study assesses the acceptability and feasibility of delivery strategies for the vaccine candidates M72/AS01e and MTBVAC in Ethiopia, Nigeria, and Tajikistan.

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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