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M72/AS01e

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

M72/AS01e
Ongoing
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

Prep4TBVax

2023-2025
M72/AS01e, MTBVAC
Planned
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

2021 - 2024
M72/AS01e
Ongoing
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.

Feasibility of novel adult tuberculosis vaccination in South Africa: a cost-effectiveness and budget impact analysis

2022
M72/AS01e
Completed
We conducted expert interviews to identify plausible vaccination implementation strategies for the novel M72/AS01E vaccine candidate. The strategies were defined in terms of target population, coverage, vaccination schedule and delivery mode. We modelled these strategies to estimate long-term resource requirements and health benefits arising from vaccination over 2025–2050.
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