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Vaccines against Lassa virus diseases – Joint call with the Coalition for Epidemic Preparedness Innovations (CEPI)

Status: Planned
Type of action: Research and Innovation Action (RIA)
Call budget: € 40 million
Funding level: 100% of eligible costs
Open date: 2 November 2019, 00:00
Close date: 7 April 2020, 17:00
Go to EDCTPgrants

Expected number of grants: 1-2

Call identifier: RIA2019LV

Description

Background
Vaccines have contributed enormously to the successful control and elimination of many diseases, but few vaccines have so far been developed for the prevention and control of emerging infectious diseases. Lassa virus (LASV) has been added to the WHO R&D Blueprint list of diseases for which there is an urgent need for accelerated research and development, considering the disease’s potential to cause a public health emergency, and given the absence of efficacious drugs and/or vaccines. In the coming years, several candidate vaccines against LASV will enter clinical development and there is an urgent need to fast track their development. The aim is to facilitate the development of promising vaccines and the preparation of investigational sites in affected countries to be ready to perform proof of concept and/or pivotal efficacy trials.

Scope
The purpose of this call for proposals is to support distinct strategic actions (clinical research activities) which are part of efforts to prepare and conduct a large-scale clinical trial that has the potential to achieve proof of concept and/or the demonstration of pivotal efficacy of novel candidate vaccines against LASV.

Applications are invited for large-scale collaborative projects which include one or more clinical trials (phase II to III) aiming to accelerate the clinical development of Lassa candidate vaccines. Applications must include a minimum of one clinical trial to be conducted in affected countries in sub-Saharan Africa to test the safety, immunogenicity and/or efficacy of a candidate vaccine. Proposals that include phase III trials are particularly encouraged.

Projects should incorporate activities to enhance the capacity of existing trial sites and/or develop new trial sites in affected countries in sub-Saharan Africa for the conduct of vaccine trials. These activities could include observational (site set-up) studies, retrospective evaluation of available epidemiological data and prospective cohort studies to define incidence and case definitions for subsequent efficacy trials. Strengthening of laboratory testing capacity for case ascertainment and product evaluation is considered in scope when necessary for supporting the proposed clinical trial(s). This could include the evaluation of newly developed or newly standardized diagnostic assays for LASV and immunological read-outs for vaccine performance as well as the setup or strengthening of regional or in-country biobanks for sample storage and archiving.

These activities would ideally build on and leverage existing or developing networks of excellence or ongoing capacity development of researchers, institutions, and sites, including existing national or regional biobanking facilities, in sub-Saharan Africa, to conduct clinical trials and related research, including observational studies. The inclusion of plans to involve public health authorities in disease-endemic countries is also encouraged.

Supporting information on the composition and scale, as well as on the management structures and procedures of the large-scale clinical trial must be presented to enable assessment of their appropriateness.

The EDCTP Association and CEPI consider that proposals for actions of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately. When the EDCTP Association and CEPI deem participation of the entity essential for carrying out the action, legal entities from anywhere in the world will be eligible for funding through this call for proposals.

Expected impact
Actions supported under this call for proposal should advance the development of promising LASV candidate vaccines moving towards regulatory licensure. The actions should also contribute towards a better understanding of the mechanisms of the reactogenicity (safety), immunogenicity and efficacy profile of the LASV candidate vaccine(s) and build capacity for the evaluation of vaccines against LASV and other EIDs in sub-Saharan Africa.

Capacity-enhancing activities should contribute to strengthening regional, national, institutional and individual capacities to conduct clinical trials for product evaluation according to ICH-GCP standards and generate data to inform trial design and appropriate endpoints.

Eligibility
A proposal/application will only be considered eligible if:

  1. its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
  2. it complies with the eligibility conditions for participation set out below, depending on the type of action:
    • At least three legal entities. Two of the legal entities shall be established in two different Participating States (European Partner States)* and one of the legal entities must be established in a sub-Saharan African** country. All three legal entities must be independent of each other.
    • ‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.

 

Notes

*The Participating States (European Partner States) are Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.

**The following sub-Saharan African countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic People’s Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Ethiopia, Equatorial Guinea, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé and Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia, and Zimbabwe.

Procedure and application process

Submission and evaluation procedure
This is a single-stage application procedure. Proposals must be submitted by 7 April 2020, 17:00 CET via EDCTPgrants. Evaluation results are expected to be made available by 30 June 2020.

Evaluation, scoring, and thresholds
Following an admissibility and eligibility check, full proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria Excellence, Impact and Implementation (see Article 15 of the Horizon 2020 Rules for Participation Regulation No 1290/2013). Each criterion will be scored out of 5. The threshold for individual criteria will be 3. The overall threshold, applying to the sum of the three individual scores, will be 10.

For all proposals involving human participants, and/or human tissues, cells or personal data, the evaluation process will include an assessment of ethical issues.

The following aspects are considered under the evaluation criteria:

1. Excellence

  • Fit with the scope and objectives of the EDCTP2 programme, the EDCTP Association strategic research agenda and the call topic description;
  • Importance, relevance/pertinence, and clarity of the objectives;
  • The soundness of the concept and credibility of the proposed approach/methodology.
  • Importance of the question being addressed and the rationale/need for the proposed clinical trial(s) or research study now;
  • Excellence and appropriateness of the clinical trial design, including the proposed location(s) of the trial;
  • The extent to which the proposed trial will advance the field. In particular, how it differs from or complements any relevant planned, ongoing or recently completed trials internationally;
  • Appropriate consideration of interdisciplinary approaches, and where relevant, use of stakeholder knowledge and gender dimension in research and innovation content.

 

2. Impact

  • Call specific aspects as listed under ‘expected impact’ in each individual call;
  • The extent to which the outputs of the proposed work would contribute, at the European, African and/or International level, to each of the expected impacts listed in the work plan under the relevant topic;
  • Likelihood to result in major advances in the field with a potential benefit of the research to the affected populations;
  • Advancing the clinical development of new and improved products;
  • Generalisability of the trial/study results beyond the immediate research setting in a way that will maximise the impact of the results;
  • Contribution to improved disease management and prevention through changes in policy and practice, with the ultimate goal of improving public health;
  • Contribution to strengthening the capacity in sub-Saharan Africa to conduct clinical trials;
  • Effectiveness and quality of the proposed measures to exploit and disseminate the project results (including management of IPR) to communicate the project activities to different target audiences, and to manage research data.

 

3. Quality and efficiency of the implementation

  • Quality and effectiveness of the work plan, including the extent to which the resources assigned to work packages are in line with their objectives and deliverables;
  • Appropriateness of the management structures and procedures, including risk and innovation management, and how responsibilities for research data quality and sharing, and security will be met;
  • Complementarity of the participants within the consortium, and the extent to which the consortium as whole brings together the necessary expertise;
  • Appropriateness of the allocation of tasks and resources, ensuring that all participants have a valid role and adequate resources in the project to fulfil that role.
  • Feasibility and appropriateness of the methods and project management to achieve the objectives within the timeframe of the grant;
  • Compliance with national and international standards of research, Good Clinical Practice, ethics- and safety-related issues;
  • Participants have the operational capacity, to carry out the proposed work, based on the competence and experience of the individual participant(s);
  • Competence of the participants and their investigators in conducting trials according to international standards of Good Clinical Practice (ICH-GCP);
  • Involvement of sub-Saharan African researchers in the scientific leadership of the clinical trial;
  • Arrangements and plans to take forward clinical development of the products under evaluation (where applicable).

 

For this call for proposals, the Coordinator has a ‘right to reply’ to the expert assessments (rebuttal procedure).

Financial provisions

  • The call budget is EUR 40 million;
  • The funding level is 100% of eligible costs.

 

Grant agreement
Participants in actions resulting from this call for proposals will be required to conclude a consortium agreement prior to the conclusion of the General EDCTP2 grant agreement (multi-beneficiary).

Application process

  • The application must be submitted online via EDCTPgrants;
  • Only registered users of EDCTPgrants system can apply for grants and therefore you are advised to register on the system as soon as possible.

 

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