Vaccine development for poverty-related and neglected infectious diseases: tuberculosis

Specific challenge: Vaccines offer a safe and cost-effective way to protect large populations against infectious diseases, or at least to mitigate the clinical course of these diseases. Yet many poverty-related and neglected infectious diseases continue to escape attempts to develop effective vaccines against them.

Disappointing results of recent clinical trials point to bottlenecks in identifying viable candidate vaccines, which if unaddressed will continue to present significant risks of failure at relatively late stages of the development process.

The specific challenge will be to shift this ‘risk curve’ in order better to select successful vaccine candidates (and discard those with a higher risk of failure) at an earlier stage of the vaccine development process.

Scope: Proposals should focus on strengthening the capacity for discovery and early development of new vaccine candidates for tuberculosis by addressing all of the following inter-related elements:

1. Establishment of a platform for the identification of several new diverse and novel vaccine candidates for tuberculosis, and their pre-clinical and early clinical testing.

2. The major bottlenecks in vaccine development should be addressed; in particular better ways for early distinction between successful candidates and those that will eventually fail in late stage clinical trials. Proposals should therefore address areas such as in vitro and in silico testing, predictive animal models, predictive correlates of protection, phase 0 trials, first in man trials and innovative risk prediction methods, taking into account potential sex-specific differences. Based on specific gating and priority setting criteria the most promising new vaccine candidates for tuberculosis should be compared with other candidates and selected in an objective and transparent process according to their merits in line with effective vaccine portfolio management.

3. The successful proposal shall be part of the Global TB Vaccine Partnership and continue its vaccine development in the context of this initiative in collaboration with the European and Developing Countries Clinical Trials Partnership (EDCTP), and a pathway and commitment towards this must form an integral part of the proposal.

In line with the Union’s strategy on international cooperation^[1] in research and innovation, international cooperation is encouraged. The proposals should also address the barriers and possible facilitators regarding the uptake and implementation of a new vaccine in low, middle and high income countries in different regions of the world.

The Commission considers that proposals requesting a contribution from the EU of between EUR 15 and 25 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected impact: This should provide:

• Reduction in the cost associated with late stage vaccine failure, increasing the number of other candidates which can be tested with the same resources, thus increasing the chance of discovery of an effective vaccine
• Contribution to the implementation of  the Global TB Vaccine Partnership for the development of tuberculosis vaccines and, (currently under development in collaboration with European Investment Bank and Bill and Melinda Gates Foundation) including the establishment of close links with the European and Developing Countries Clinical Trials Partnership (EDCTP).

Type of action:Research and innovation actions

[1] COM(2012)497