H2020-PHC-2014-single-stageSub call of: H2020-PHC-2014-2015
|Opening Date||11-12-2013||Deadline Date||15-04-2014 17:00:00 (Brussels local time)|
|Publication date||11-12-2013||Total Call Budget||€185,200,000|
|Status||Closed||Main Pillar||Societal Challenges|
|OJ reference||OJ C 361 of 11 December 2013|
|Topic:||Vaccine development for poverty-related and neglected infectious diseases: tuberculosis||PHC-08-2014|
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 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
Please read carefully all provisions below before the preparation of your application.
- List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects supported under all topics in calls under the Societal Challenge ‘Health, demographic change and well-being’.
- Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme
3.1 Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme, with the following exceptions:
-The thresholds for each criterion in a single stage process will be 4, 4 and 3. The cumulative threshold will be 12.
- If a proposal fails to achieve the threshold for a criterion at any stage, the evaluation of the proposal will be stopped.
- For the evaluation of topics PHC7 – 2014 and PHC8 – 2014, the Commission will organise hearings at stage 1 with applicants as part of the panel deliberations for all proposals above threshold.
3.2 Guide to the submission and evaluation process
- Proposal page limits and layout: Please refer to Part B of the standard proposal template.
- Indicative timetable for evaluation and grant agreement:
Information on the outcome of one-stage evaluation: maximum 5 months from the final date for submission.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
- Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template (administrative forms and structure of technical annex)
Annotated Model Grant Agreement
For information, a pdf. template of the evaluation form for this topic is available on the call page under call documents. In addition, to be consulted on the same page a specific template for essential information for clinical trials/studies/investigations is available.
- Additional provisions:
Horizon 2020 budget flexibility
- Open access must be granted to all scientific publications resulting from Horizon 2020 actions, and proposals must refer to measures envisaged. Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
You can download the same documents as one zip file from the call page
- FAQ en
- Evaluation form for H2020-PHC-2014-single-stage-topic 31 - RIA en
- Evaluation form for H2020-PHC-2014-single-stage-topics 7-8-15-19-26 RIA en
- Evaluation form for H2020-PHC-2014-single-stage CSA en
- Essential information for clinical trials/studies/investigations en
- Commission Decision_clinical study reimbursement based on unit costs en
- A guide to ICT-related activities in WP2014-15 en
No submission system is open for this topic.