TBVI consortium key achievements
TBVI and its partners build on the highly successful and long-standing collaborations in subsequent EC-FP5-7, H2020 and Horizon Europe funded TB vaccine and biomarker projects and holds strong partnership with the Global TB Vaccine Partnership. TBVI collaborates with partners from excellent laboratories from Europe, USA, Asia, Africa and Australia, many of which are global leaders in the TB field.
The impact of European investment in TB R&D is evidenced by the fact that almost 50% of the TB vaccine candidates in the global preclinical and clinical pipeline originate from the TBVI consortium.
Discovery
Over the past years, 45 different novel vaccine strategies have been pursued and more than half of these have moved from research to discovery. These strategies have included genome-wide protein and glycolipid antigen discovery, development and testing of novel delivery systems, adjuvants and improved live vaccines.
The H2020 funded project TBVAC2020, evaluated from 2015-2019 a range of different and innovative approaches in vaccine discovery, 25 new vaccine approaches and platform technologies have been identified that are applied to the development of novel TB vaccine candidates, and to development of vaccines in a range of other infectious diseases.
(Pre-)clinical development
By using independent head-to-head testing in ‘standardised’ centralised preclinical models and by applying a globally accepted stage gating and portfolio assessment. In TBVAC2020 13 new promising candidates have been identified, 7 of which showed improved efficacy over the existing BCG vaccine. Also new and improved preclinical evaluation models have been established, for example a novel pre-clinical prime-boost model to evaluate innovative prime-boost strategies.
The current Horizon-Europe project, TBVAC-HORIZON, aims to improve the understanding of lung immunity to tuberculosis infection and to establish a diversified innovative TB vaccine pipeline targeting mucosal immunity and will include the continuation of head-to-head testing.
Biomarkers
A unique global platform for TB biomarker research and development has emerged through candidate testing as well as by combining the leading TB biomarker research groups in EU with leading African TB biomarker and clinical research sites. This resulted in a rich pipeline of biomarkers including potential correlates of protection that may enable the identification of protective antigens and effective vaccines at a much earlier stage in development.
Clinical development
A number of TB vaccine candidates discovered and developed with the support of TBVAC2020, and its FP6 and FP7 predecessors have progressed to clinical stages and secured support from EDCTP for further (clinical) development. TB vaccine pipeline
Tools to facilitate the R&D infrastructure
A team of scientific and technical experts from TBVI and IAVI with the input of the TB vaccine community established the ‘TB Vaccine Development Pathway’. This tool has been developed on behalf of the Global TB Vaccine Partnership (GTBVP). It serves as a guidance tool to help developers consider all the functions of development and to advance a vaccine to its next stage of development (www.TBvacpathway.com )
The Horizon Europe project ITHEMYC, aims to establish a critical path for selection of promising innovative adjunct TB immunotherapies and progress 2 of these immunotherapies to completion of preclinical proof of concept.
On behalf of EDCTP, TBVI together with experts develops and establishes a set of guidance documents and web-based tools and a comprehensive registry of trial sites in sub-Saharan Africa with capacities to conduct TB vaccine studies (Support tools for TB vaccine R&D). To promote collaboration among EDCTP funded actions, TBVI also organises stakeholder meetings as well as knowledge sharing activities with the broader TB vaccine research community in Africa and Europe.
Resource mobilisation
TBVI has received continued support from EC and several institutions as well as from national governments outside the EU, among others Switzerland, South Korea and Australia. TBVI was awarded for Stage and Target specific Gating criteria that can be used by funders and developers for rational selection and to guide development of TB vaccine candidates. Furthermore, TBVI receives support from the Dutch Ministry of Public Health, Welfare and Sports. And TBVI is involved in two TB-vaccine clinical trial projects from EDCTP (European & Developing Countries Clinical Trials Partnerships). From 2019 onwards, TBVI runs the secretariat for the Global Tuberculosis Vaccine Partnership.
Knowledge sharing
On an annual basis TBVI organizes a meeting where over 100 leading scientists share data and results on ongoing TB vaccine and biomarker R&D projects. The consortium published many articles in peer reviewed journals.
Overview of TBVI consortium vaccine candidates.
Maintaining excellence
TBVI’s strategy and activities contribute to maintaining and extending European and global partners’ leadership and excellence in discovery and development of new TB vaccines and biomarkers.