New drugs and vaccines for priority pathogens in antimicrobial resistance – 2019

Description

Background
Antimicrobials are designed to kill or stop the growth of disease-causing pathogens, but many of them have become increasingly ineffective due to emerging resistance by the targeted bacteria, viruses, protozoa or fungi. Selection pressure naturally leads to the emergence of resistance whenever microbes are exposed to agents who are meant to kill them or inhibit their growth, and the potential spreading resistance can take days or years. Pathogens can also develop resistance to multiple agents, and as a result, very hard to control multi-drug resistant infections emerge and spread.

To guide and promote research and development of new antibiotics and vaccines, the WHO has established a list of antibiotic-resistant priority pathogens.* While new or improved antimicrobials is an essential tool to combat resistant pathogens at the patient level, the first line of defense for containing the spread of antimicrobial resistance (AMR) at the population level is an effective system to diagnose, detect, collect and integrate information about antimicrobial resistance on a large scale. In the context of large programmes to address AMR, isolated efforts will have very limited impact, and only coordinated actions will lead to a successful response against the emergence and spread of AMR.

Scope
The purpose of this call for proposals is to provide funding for clinical trials to be conducted in sub-Saharan Africa which aim to develop new or improved medicinal products (drugs and vaccines) or combinations thereof against pathogens from the WHO priority list that also fall within the scope of the EDCTP2 programme, specifically Campylobacter, Salmonella, Streptococcus pneumoniae, and Mycobacterium tuberculosis.

Proposals should include at least one clinical trial (phase I to IV) in sub-Saharan Africa. Proposals should clearly define the activities and mechanisms to be used within the project, including details of any collaboration with public authorities, international organisations or commercial partnerships that will be established in order to achieve the expected impact.

The proposal must include full details of the product development milestones including specific go/no-go criteria for the proposed clinical trial(s) as well as specific plans for the subsequent regulatory approval process.

Projects should include a detailed exploitation plan that describes how project results will be translated into products, policy or practice. The EDCTP Association considers that proposals for actions of between 36- to 60-months duration would allow this specific challenge to be addressed appropriately.

Expected impact
Projects funded under this call for proposals should contribute towards national and international plans for containment of antimicrobial resistance.

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

*WHO: Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug-resistant bacterial infections, including tuberculosis

**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 proces

Submission and evaluation procedure

This is a single-stage application procedure. Proposals must be submitted by 7 November 2019, 17:00 CET via EDCTPgrants. Evaluation results are expected to be made available by 30 March 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;
• 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;
• 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 the 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 18 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

More information

• EDCTP2 Frequently Asked Questions about calls for proposals
• For specific questions related to this call for proposals, please contact: Michelle Nderu at nderu@edctp.org
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants@edctp.org.
• For guidance on applying to EDCTP, please refer to the Templates, guides and policies section of the EDCTP website
• The EDCTP2 programme runs until the end of December 2024. Applicants should take into consideration the programme end date when planning their proposals.

Projects awarded under this call

BETH-TB
Isoniazid resistance: Resetting the score with boosted ethionamide

TASK Foundation NPC (TASK), Cape Town, South Africa, with partners in France and Spain
Project coordinator: Prof. Andreas Diacon
Starting date: 01 January 20121
Duration: 30 months
EDCTP grant amount: EUR 2,704,719
Grant agreement: RIA2019AMR-2657

PanTB-HM
A novel pan-TB regimen targeting both host and microbe

The Aurum Institute NPC, Johannesburg, South Africa, with partners in Germany, Mozambique, the Netherlands, South Africa, Tanzania, and the United States of America
Project coordinator: Dr Robert Wallis
Starting date: 01 October 2020
Duration: 60 months
EDCTP grant amount: EUR 8,140,565
Grant agreement: RIA2019AMR-2647

PEDVAC-iNTS
Pediatric phase I/II age de-escalation dose-finding study of a vaccine against invasive non-typhoidal salmonellosis in sub-Saharan Africa

Sclavo  Vaccines Association (SVA), Siena, Italy, with partners in Germany, Ghana, Italy, and Switzerland
Project coordinator: Dr Rino Rappuoli
Starting date: 01 March 2021
Duration: 48 months
EDCTP grant amount: EUR 5,698,964
Grant agreement: RIA2019AMR-2658