TBVI consortium key achievements
Over the past ten years, 40 different novel vaccine strategies have been pursued and 22 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.
Over the past ten years, TBVI projects have delivered 6 vaccine candidates moving from discovery to the preclinical phase, and 4 vaccine candidates going to Phase I clinical trials. Preclinical models The TBVI consortium has established a novel pre-clinical prime-boost model to evaluate innovative prime-boost strategies.
A series of new TB biomarker signatures has been identified through candidate testing as well as through unbiased biomic approaches. Assays suitable for use in large-scale monitoring studies (e.g. in TB endemic areas) have been developed.
The Phase I trial of vaccine candidate MTBVAC, conducted at the University of Lausanne, was completed in 2014. The safety and immunogenicity results of this trial were satisfactory. After successfully conducted a Phase Ib trial, a Phase IIa trial will start end of 2018.
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 . In 2017 a one million dollar grant was awarded to TBVI for Stage and Target specific Gating criteria (SG criteria II) to be applied 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. And TBVI is involved in four TB-vaccine clinical trial projects from EDCTP (European & Developing Countries Clinical Trials Partnerships).
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.
The impact of TBVI’s strategy
Innovating and diversifying the pipeline
Operationalising TBVI’s strategy in the coming four years is expected to result in support for 20 new discovery approaches, up to 6 candidates at preclinical stages and up to 6 candidates at early clinical stages. In addition, it will identify, optimise and evaluate 15 innovative approaches on biomarkers.
Reducing TB disease burden and the cost to the global community
The vast majority of TB cases occur in developing countries, especially in adolescents and adults between 15 and 45 years of age, the economically most active segment of the population. Modeling studies show that more effective TB vaccines will have a significant impact on the TB disease burden, including drug resistant TB. The development of a new vaccine by means of a preclinical and clinical portfolio management approach is estimated to cost approximately €600 million over the next ten years. This investment seems relatively small when compared to the estimated costs of TB disease in Europe or globally over this period, which are estimated to be €5.9 and €58 billion respectively.
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.