TBVI will continue
- To support consortium partners to innovate and diversify the vaccine and biomarker pipelines and to move promising candidates through preclinical and early clinical development.
- To strengthen its knowledge-sharing platform, expand its research and strategic partner network and diversify its funding sources.
- To support global efforts to accelerate TB vaccine discovery and development through increasing innovation, collaboration and coordination.
To fill and diversify the pipeline of vaccine candidates and strategies, TBVI aims to support 20 approaches, focusing on:
- discovery of new vaccine targets by innovative approaches that allow the identification of non-classical vaccine antigens like non-protein antigens and subdominant epitopes and novel protein candidates
- exploration and implementation of innovative immunisation strategies and vaccine delivery platforms
- optimisation of promising sub-unit and live vaccine candidates by, inter alia, the use of novel delivery and adjuvant platforms
TBVI aims to support at least 6 vaccine candidates in preclinical development. Preclinical activities include:
- optimising immunogenicity and adjuvant combinations of vaccine candidates
- GMP manufacturing
- formulation and toxicology studies of novel candidates
- testing candidates in standardised preclinical models
- developing and implementing new or improved preclinical models with greater relevance to the target product profile (TPP) and clinical vaccine efficacy
TBVI aims to support 15 innovative approaches. This will be done through the following activities:
- identification of biomarkers
- development of corresponding correlate tests
- evaluation of correlates in a comprehensive series of human TB cohorts from genetically and geographically diverse populations
- study of correlates of risk of TB disease and infection in human cohorts
- building a TB biomarker database for tailor-made biomarker selection
TBVI aims to accelerate and support promising candidates to early clinical development (up to Phase IIa):
- 2-6 candidates in early clinical experimental medicine studies, including comparative first-in-man trials
- development of a safe and controlled human challenge model for TB
- 2 candidates in Phase I and IIa trials
Portfolio management will be continued to evaluate and advise during the development process, and to prioritise vaccine candidates. TBVI will continuously work with its partners to refine the portfolio management criteria and build consensus. TBVI will coordinate with stakeholders to expand the use of its portfolio management process in a global context.