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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.

Measuring indirect transmission-reducing effects in tuberculosis vaccine efficacy trials: why and how?

Tuberculosis is the leading bacterial cause of death globally. In 2021, 10·6 million people developed symptomatic tuberculosis and 1·6 million died. Seven promising vaccine candidates that aim to prevent tuberculosis disease in adolescents and adults are currently in late-stage clinical trials. Conventional phase 3 trials provide information on the direct protection conferred against infection or disease in vaccinated individuals, but they tell us little about possible indirect (ie, transmission-reducing) effects that afford protection to unvaccinated individuals. As a result, proposed phase 3 trial designs will not provide key information about the overall effect of introducing a vaccine programme. Information on the potential for indirect effects can be crucial for policy makers deciding whether and how to introduce tuberculosis vaccines into immunisation programmes. We describe the rationale for measuring indirect effects, in addition to direct effects, of tuberculosis vaccine candidates in pivotal trials and lay out several options for incorporating their measurement into phase 3 trial designs

An effective vaccine is only the first step: the need to create and sustain demand for TB vaccines

Understanding public willingness to receive new TB vaccines, as well as defining how to address any barriers to acceptance, will be key to ensuring that the promise of these vaccines can be fully realized. Although we can learn from previous vaccine intro ductions, it is imperative we close key research gaps specific to new TB vaccines. This will inform the development of interventions to generate and sustain high demand for TB vaccines in communities that stand to benefit the most

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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