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.
This project aims to collect data to: 1) Assess health facility and health systems readiness for a new TB vaccine, and 2) Explore decision-making factors for new TB vaccine demand and acceptance
This is a mixed-methods study collecting information on willingness to receive a new TB vaccine among adolescents, their caretakers, and adults in Mozambique, a high TB burden country, to assess potential barriers to high uptake of new TB vaccines.
Evidence-based matrixing approach to identify priority countries and target populations through an iterative process, engaging a set of diverse stakeholders
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.
Vaccines will be introduced in contexts where TPT already exists. Exploration of possible study designs, expected effectiveness, feasibility of integrated approaches is key.