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TOPIC : Stratified host-directed approaches to improve prevention, treatment and/or cure of infectious diseases

Topic identifier: SC1-BHC-14-2019
Publication date: 27 October 2017

Types of action: RIA Research and Innovation action
DeadlineModel:
Planned opening date:
two-stage
26 July 2018
Deadline:
2nd stage Deadline:
02 October 2018 17:00:00
16 April 2019 17:00:00

Time Zone : (Brussels time)
  Horizon 2020 H2020 website
Pillar: Societal Challenges
Work Programme Year: H2020-2018-2020
Topic Description
Specific Challenge:

Despite major advances in development of new drugs and vaccines against infectious diseases, many of the therapies and preventive measures do not result in the expected favourable health outcomes for various reasons. The pathogen might be resistant to the treatment, or a required immune response might not be provoked to contain the infection; the used drug might not reach the pathogen, or the pathogen might escape the host defence mechanisms. In addition, each individual might be responding differently to the intervention, making it difficult to make one intervention fit all patients. A promising avenue to overcome treatment failure in infectious diseases is to develop novel therapeutic or preventive approaches on the basis of specific factors identified in the host or the host-pathogen interaction. This approach provides the basis for stratification of individuals based on these characteristics and tailor the treatment or the preventive measure accordingly.

Scope:

Proposals should test emerging concepts in drug and/or vaccine development in order to address the problem of antimicrobial drug resistance and to optimize therapeutic, curative or preventive measures against infectious diseases of major concern for Europe. Proposals should capitalize on knowledge of the role of host factors, immune-modulators or of host-pathogen interactions influencing disease outcome that can be utilized to strengthen the response to treatment or prevention measures. This should lead to new enhanced therapies, cures and/or preventive measures. Differences in factors such as age, gender and genetic variation among the human population should be taken into consideration.

The proposals should focus on late pre-clinical and/or clinical research, supporting proof of concept and selecting relevant biomarkers for clinical validation. They should take advantage of existing or newly established cohorts to help identify factors for predicting the course of the disease and its response to the intervention in stratified patients.

The downstream constraints for the uptake of the intervention by national health systems should be taken into account. The suitability, acceptability and adaptability of the interventions to be developed should be addressed and assessed for different population groups and will thus require expertise from the social sciences and the humanities.

The Commission considers that proposals requesting a contribution from the EU of between EUR 6 and 10 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:
  • Increase Europe's capacity to control infectious diseases.
  • Enriched product development pipelines with novel, potentially more effective, targeted treatments, cures and/or preventive measures for infectious diseases and/or validated biomarkers with potential for rapid uptake into clinical practice.
  • Reduced burden of major infectious diseases.
  • Contribute to the achievement of the European One Health Action Plan against Antimicrobial Resistance.
  • Contribute to the achievement of the Sustainable Development Goal 3, ensure health and well-being for all, at every stage of life.
Cross-cutting Priorities:

Socio-economic science and humanities
Gender

Topic conditions and documents

1. Eligible countries: described in Annex A of the Work Programme.
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. See the information in the Online Manual.

2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.

Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.

The thresholds for each criterion in the second stage of a two-stage process will be 4, 4 and 3. The cumulative threshold will be 12.

3. Evaluation:

  • Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
  • Submission and evaluation processes are described in the Online Manual.

4. Indicative time for evaluation and grant agreements:

Information on the outcome of evaluation (two-stage call):

For stage 1: maximum 3 months from the deadline for submission.
For stage 2: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.

5. Proposal templates, evaluation forms and model grant agreements (MGA):

Research and Innovation Action:

Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement

Essential information for clinical studies

6. Additional provisions:

Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.

Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.

7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.

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.

Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.

Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.

Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.

Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.

Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.

The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.

8. Additional documents:

Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020

Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme

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The submission system is planned to be opened on the date stated on the topic header.

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