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TOPIC : Towards a next generation influenza vaccine to protect citizens worldwide – an EU-India collaboration

Topic identifier: SC1-BHC-32-2019
Publication date: 27 October 2017

Types of action: RIA Research and Innovation action
DeadlineModel:
Opening date:
single-stage
26 July 2018
Deadline: 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:

Seasonal influenza is a major health burden, with an estimated 500,000 deaths around the world each year.[1] A further threat from influenza is the non-seasonal emergence of new strains, which have the potential to result in major influenza pandemics.

Despite the large danger posed by both seasonal and pandemic influenza, vaccines against flu are only moderately effective.[2] In addition, current influenza vaccines need to be developed every year, as they only work against a narrow range of the hugely variable influenza subtypes, and are also highly vulnerable to strain mutations after an annual vaccine has been developed. Improved influenza vaccines would simultaneously ease a significant global health burden, and help the international community to better prepare in the event of an influenza pandemic.

The burden of seasonal influenza, and the ever-present threat of a new influenza pandemic, is a high priority for both Europe and India. In recent years, significant progress has been made by teams in India and Europe on influenza vaccination. To build on this shared recognition of the importance of influenza, as well as significant expertise available in both regions, a renewed effort by India and Europe towards the development of a next generation influenza vaccine is needed. Furthermore, utilisation of the human challenge model of influenza, or work to improve the model itself, may be an important step to progress this essential field.

Scope:

Proposals should further the advancement of next generation influenza vaccine candidate(s) with improved efficacy and safety, duration of immunity, and reactivity against an increased breadth of influenza strains. Proposals should make use of new knowledge of, for example, structural biology, immunology, genetics and genomics, influenza transmission modelling, vaccine production, formulation and delivery methods.

Proposals should cover at least pre-clinical and/or early clinical research, selecting promising vaccine candidate(s), supporting their proof of concept, showcasing new pre-clinical or clinical knowledge.

The approach taken should include validation of one or more candidate vaccine(s) in a human challenge model[3] of influenza, and/or work to improve the influenza human challenge model itself. This latter work could include comparative testing of potential human challenge strains, and the responses they elicit in volunteers.

The suitability of the interventions to be developed should be addressed and assessed for different population groups, as should the suitability of the candidate(s) to low- or middle-income settings. The downstream constraints for the uptake of the intervention by national health systems should be taken into account.

Due to the specific challenge of this topic, in addition to the minimum number of participants set out in the General Annexes, proposals shall include at least three participants from India. For more information, interested entities in India shall consult the website of the Department of Biotechnology (DBT) http://www.dbtindia.nic.in/funding-mechanism/call/# , where DBT will indicate the eligibility conditions to Indian applicants. Proposals should include participants from a variety of different disciplines.

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:
  • Further the development of a vaccine that could be effective against an increased breadth of seasonal strains and/or from the outset of a large-scale influenza pandemic.
  • Utilisation of and/or further improvement of the human challenge model of influenza as a tool for candidate vaccine(s) assessment.
  • Contribute to the reduction of the burden of influenza outbreaks worldwide, particularly in Europe and India. Contribute to the achievement of Sustainable Development Goal 3, to ensure health and well-being for all, at every stage of life.
  • Specific to India, boost initiatives like the National Health Mission[4] and Biopharma Mission [Innovate in India (I3)][5] of the Government of India by developing affordable biopharmaceuticals, including vaccines, for citizens the world over.
Cross-cutting Priorities:

International cooperation

[1]World Health Organization seasonal influenza factsheet: http://www.who.int/mediacentre/factsheets/fs211/en/

[2]ECDC, Influenza vaccination: https://ecdc.europa.eu/en/seasonal-influenza/prevention-and-control/influenza-vaccination

[3]Human Challenge Trials for Vaccine Development, World Health Organization: www.who.int/biologicals/expert_committee/Human_challenge_Trials_IK_final.pdf

[4]National Health Mission, Government of India: http://www.nhm.gov.in/nhm.html

[5]Innovate in India (i3), Government of India: http://www.dbtindia.nic.in/press-release-for-launch-of-national-biopharma-mission/

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.

Due to the specific challenge of this topic, in addition to the minimum number of participants set out in the General Annexes, proposal(s) shall include at least three participants from India.

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

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.

The thresholds for each criterion in a single stage process will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.

4. Indicative time for evaluation and grant agreements:

Information on the outcome of evaluation (single-stage call): 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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Type of Action Research and Innovation action [RIA]
Topic Towards a next generation influenza vaccine to protect citizens worldwide – an EU-India collaboration - SC1-BHC-32-2019
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