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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

TB vaccine advocacy roadmap

The TB Vax ARM represents a global coalition of TB stakeholders, including TB survivors, civil society organizations, and non-profits, invested in TB vaccine advocacy and research, and seeks to provide coordinated advocacy efforts that are complementary to ongoing TB vaccine R&D and policy efforts. The TB Vax ARM holds regular virtual calls with partners and guest speakers from around the world. WGNV coordinates with the TB Vax ARM on global advocacy activities. For more information go to: https://newtbvaccines.org/take-action/

Evidence considerations for vaccine policy development for tuberculosis vaccines intended for adults and adolescents

The ECVP facilitates early engagement and alignment across the stakeholders involved in vaccine development and those responsible for vaccine regulatory, policy, funding and country introduction decisions. This framework aims to anticipate and collectively delineate the clinical trial, observational, and other data likely to be required by global and national policymakers, and to do so when most valuable – during development of the late-stage clinical plan, including the design of the pivotal licensure trial.
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