Community Research and Development Information Service - CORDIS

H2020

TBVAC2020 Report Summary

Project ID: 643381
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - TBVAC2020 (TBVAC2020; Advancing novel and promising TB vaccine candidates from discovery to preclinical and early clinical development)

Reporting period: 2015-01-01 to 2016-06-30

Summary of the context and overall objectives of the project

TBVAC2020 builds on the highly successful, long-standing collaborations in previous EC-FP5-, FP6- and FP7-funded Tuberculosis (TB) vaccine and biomarker R&D projects. New key partners, global leaders in the TB field, from Europe, USA, Asia, Africa and Australia, now also became members.

TBVAC2020 aims to innovate and diversify the TB vaccine pipeline by accelerating the development of ongoing and novel candidate vaccines. This is achieved by combining bottom-up approaches for vaccine discovery (WP1), by developing new preclinical models addressing clinical challenges (WP2) and by identifying and validating correlates of protection (WP5) with top-down portfolio management for vaccine candidate selection by comparative evaluation (WP6) and by comparative, head-to head preclinical and early clinical evaluation (WP3, WP4).

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In its first 18 months TBVAC2020 has obtained the following remarkable interim results:

1) Through a variety of immunity-directed approaches in mice and humans several novel Mycobacterium tuberculosis (Mtb) antigens and epitopes were identified that are being evaluated for immunogenicity and protective efficacy in (pre)clinical models. In parallel innovative unbiased technologies led to the successful discovery of novel Mtb protein and lipid antigens.
In addition, novel antigen delivery platforms were developed, and novel strategies for mucosal vaccination implemented, both of which are now tested in preclinical studies.
A range of new Mtb mutant constructions were generated that are undergoing evaluation as well.

2) For several candidate vaccines molecular characterisation, genetic stability investigation and quantitative drug susceptibility testing was performed. Several ZMP1 deletion mutants in different BCG background were generated for comparative future phase I clinical evaluation.

3) Clinical and immunological SOPs for future comparative phase I trials have been agreed and fixed. First trial is planned to be conducted in 2017.

4) New T cell subsets and dysfunctional B cells as biomarkers of TB disease have been identified. Investigation is ongoing.

5) The kick-off and 2nd general assembly of TBVAC2020 (complemented by the TBVI symposia) were held in Ijmuiden, The Netherlands (9-12 February 2015) and in Les Diablerets, Switzerland (February 2-5 2016), respectively. The joined over 150 attendees from 18 countries worldwide. 58 research institutions companies, SMEs, funding agencies, technical agencies and partner organizations. They shared their interim results from TBVAC2020.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

TB remains a major health threat to mankind. One-third of the world's population is currently infected by Mtb. The vast majority of TB cases occur in developing countries, mostly in individuals between 15 and 45 years of age (the economically most active segment of the population). Aside, increasing incidence and prevalence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB are challenging (e.g. 15 of 22 MDR-TB high burden countries are European). The established BCG vaccination and major global efforts to improve rapid and effective diagnosis and treatment regimens only showed limited effect to control of global spread of TB. The availability of novel effective, safe TB vaccines will have a very big impact on TB incidence and infection.

TBVAC2020 supports up to i) 20 discovery approaches, ii) 4 preclinical stage vaccine candidates, and iii) 2 candidates at early clinical stage. Improved correlates of protection will identify protective antigens, accelerate development of vaccines and allow more reliable check of immunogenicity and efficacy at an early stage. Selection and prioritization of the most promising candidate vaccines for clinical testing will reduce the protracted time scale, large size and expense of trials.

TBVAC2020 strengthens the links between academia and industry, shown by the addition of two industry partners (GSK and Transgene SA) to the consortium. GSK is developing combination vaccines for prime-boost or co-administration strategies, while Transgene is progressing a prophylactic/therapeutic vaccine based on MVA delivery of multiple Mtb antigens.

Lots of stimulatory mechanisms exist for the academic teams to translate their knowledge into product development by working together with the industry. Considering the huge size (>40 parties) of the consortium this will ensure an outstandingly high level of harmonized TB vaccine R&D within the EU, by most efficient joint use of resources.

Related information

Record Number: 192884 / Last updated on: 2016-12-15
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