TOPIC : Vaccine development for malaria and/or neglected infectious diseases
|Publication date:||14 October 2015|
|Types of action:||RIA Research and Innovation action|
|DeadlineModel: Opening date:||single-stage 20 October 2015||Deadline:||13 April 2016 17:00:00|
|Time Zone : (Brussels time)|
Topic DescriptionSpecific Challenge:
Vaccines offer a safe and cost-effective way to protect large populations against infectious diseases. Yet, many poverty-related and neglected infectious diseases continue to escape attempts to develop effective vaccines.
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 pipeline.Scope:
Proposals will have to address bottlenecks in the discovery, preclinical and early clinical development of new vaccine candidates (antigens/adjuvants) for malaria and/or neglected infectious diseases. Filoviral diseases are specifically excluded from this topic.
Depending on the maturity of the research landscape for each disease, proposals may range from large research platforms developing multiple vaccine candidates and/or vaccines for multiple diseases, to proposals specifically focused on one disease.
a) The larger platforms proposals should among others:
- Take advantage of recent advances in vaccinology (e.g. in silico analysis and novel in vitro and in vivo immunoscreens) or establish completely new approaches for the discovery and selection of novel, appropriately immunogenic antigens, and/or novel formulations/combinations for the generation of new vaccine candidates.
2. Include a systematic approach and define key gate-criteria for selection across each step of the research and development pipeline they address. Based on these criteria the most promising new vaccine candidates, should be able to be compared as early as possible in an objective and transparent process according to their merit in line with effective vaccine portfolio management.
b) Smaller proposals specifically focused on a single disease and/or a single vaccine candidate should adopt similarly innovative and comprehensive approaches to tackle one or more of the major bottlenecks in vaccine development for the specific disease.
For all antigen/vaccine candidates and for all diseases, it is necessary to ensure that a protective immune response (in the specific target population of the vaccine candidate) is adequately understood and that the candidate can elicit such a response.
Depending on the development stage, the downstream constraints of vaccine candidates for effective deployment and utilisation in resource-poor settings should be taken into account. This might include (as early clinical pipeline gate-criteria) considerations of the optimal route and immunization regime, field-deployment logistics (e.g. storing temperatures), as well as an evaluation of the predicted cost and affordability of final vaccine products. If relevant, an assessment of the target population risk-perception attitudes and immunization behaviours should be made and sex- and gender differences should be taken into account.
Both types of proposals should take into account existing mapping exercises on vaccine candidates, as well as the current vaccine development roadmaps and target product profiles for each disease (e.g. Malaria Vaccine Technology Roadmap).
The Commission considers that proposals requesting a contribution from the EU of between EUR 3 and 5 million for smaller specifically focused proposals, and between EUR 15 and 20 million for the larger platform proposals, would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.Expected Impact:
- Proposals should deliver new vaccine candidates or move existing ones along the vaccine candidate pipeline in support of the sustainable development goal No. 3.3, i.e. to end by 2030 the epidemics of malaria and neglected tropical disease
- 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.
- Increase the number and quality of vaccine candidates for malaria and neglected infectious diseases available to proceed into further development and clinical testing, if appropriate within the context of the European and Developing Countries Clinical Trials Partnership (EDCTP2).
Neglected Infectious Diseases for the scope of this call: In addition to the 17 Neglected Tropical Diseases prioritized by WHO, also eligible are childhood diarrhoeal diseases and neglected viral emerging epidemic diseases.
Topic conditions and documents
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.
Note also that a number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects (follow the links to China, Japan, Republic of Korea, Mexico, Russia, Taiwan, USA).
- Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme.
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
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.
3.2 Submission and evaluation process: Guide to the submission and evaluation process
- Indicative timetable for evaluation and grant agreement:
Information on the outcome of single-stage evaluation: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
- 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
Specific evaluation form
H2020 General MGA -Multi-Beneficiary
Annotated Grant Agreement
- 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.
- Additional documents:
H2020 Work Programme 2016-17: Health, demographic change and wellbeing
H2020 Work Programme 2016-17: Dissemination, Exploitation and Evaluation
H2020 Work Programme 2016-17: General Annexes
Legal basis: Horizon 2020 - Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
No submission system is open for this topic.
H2020 Online Manual your online guide on the procedures from proposal submission to managing your grant.
Participant Portal FAQ – Submission of proposals.
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