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Quantitative

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.

What do people want?

Investigate current TB prevention modalities vs vaccine. We lack understanding of preferences and trade offs people would be willing to make across a spectrum of issues related to study design, type of vaccines, how they are given, how often, where they are given, to whom, efficacy estimates and side effects etc.

TPTVaxx

Vaccines will be introduced in contexts where TPT already exists. Exploration of possible study designs, expected effectiveness, feasibility of integrated approaches is key.
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