TBVI consortium key achievements

Discovery

Over the past four 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.

(Pre-)clinical development

Over the past four 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.

Biomarkers

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.

Clinical development

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. MTBVAC is planned to move forward to a Phase Ib trial in South Africa in 2015.

Resource mobilisation

The TBVI consortium was awarded a €24.6 million grant from the EC and from several institutions as well as national governments outside the EU, among others Switzerland, South Korea and Australia in 2014. TBVI also received a $1,500,000 grant from the UK government (DFID) through Aeras.

Knowledge sharing

TBVI held its 10th annual meeting in February 2014, where over 100 leading scientists shared data and results on ongoing TB vaccine and biomarker R&D projects. In May 2014, inaugurated by Queen Sophia of Spain, TBVI organised an international high level scientific symposium in Madrid. The consortium published 30 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.

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.