PHC 9 – 2015: Vaccine development for poverty-related and neglected infectious diseases: HIV/AIDS

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. Furthermore, they may in combination with other treatment modalities contribute to an eradicative cure for HIV. Many poverty-related and neglected infectious diseases however 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 to better select successful vaccine candidates (and discard those with a higher risk of failure) at an earlier stage of the vaccine development process, for preventive as well as therapeutic vaccines.

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

1. Establishment of a platform for the discovery and selection of several new diverse and novel preventive or therapeutic vaccine candidates for HIV/AIDS, 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 pool expertise in the areas of 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 sex-specific differences. Based on these criteria the most promising new vaccine candidates for HIV/AIDS will be compared and selected in an objective and transparent process according to their merit.

3. The successful proposal shall continue its vaccine development in the context of the European and Developing Countries Clinical Trials Partnership (EDCTP), and a pathway and commitment towards this direction must form an integral part of the proposal. It shall also ensure collaboration with other EU-funded research actions in related research fields.

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 15 and 20 million euro 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 preventive or therapeutic 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
• Establishment of close links with the European and Developing Countries Clinical Trials Partnership (EDCTP), for the further clinical development of the vaccine candidates identified in the present initiative.

Type of action: Research and innovation actions

[1] COM(2012)497