Vaccines for diarrhoeal diseases or lower respiratory tract infections – 2018

Description

Background
Vaccines have contributed enormously towards the elimination of diseases, including the control of infectious diseases in low resource settings. Development of vaccines against diarrhoeal diseases or lower respiratory tract infections is therefore one of the preferred strategies to reduce the high mortality and morbidity of these diseases. While investment in clinical development of vaccines for diarrhoeal diseases and lower respiratory tract infections has become more substantial, additional resources are needed to support clinical trials for these vaccine candidates in sub-Saharan Africa.

Scope
This Call for Proposals will support clinical trials that can accelerate the development of vaccines for diarrhoeal infections and lower respiratory tract infections in sub-Saharan Africa.

Proposals should include one or more clinical trials (phase I to III) in sub-Saharan Africa for vaccine candidates towards one or more of the following pathogens:

• Diarrhoeal diseases: Shigella and/or enterotoxigenic E. coli (ETEC)
• Lower respiratory tract infections: Respiratory Syncytial Virus (RSV) or Group B streptococcus (GBS).

Proposals should describe the target product profiles; particularly indication, target populations, safety and/or efficacy, and describe how the candidates contribute to the global product development pipeline for the disease.

Proposals may also include detailed analyses of host responses to advance the understanding of mechanisms of reactogenicity (safety), immunogenicity and/or efficacy. Proposals should aim to incorporate the latest innovations and advances in clinical trial design and research methods that allow for rapid results, cost-effective use of available resources and reduction in subject numbers.

Full details of the clinical product development plan, including specific go/no-go criteria must be included in the proposal, as well as specific plans for the regulatory approval process and access strategy for patients in low-resource settings. The clinical trial(s) must be supported by an appropriate regulatory approval and access strategy and/or include plans for uptake into policy and practice at national or international level. The proposed clinical trial(s) must be conducted to International Council on Harmonisation – Good Clinical Practice (ICH-GCP) regulatory and ethical standards. Proposals should incorporate activities that enhance the capacity of existing trial sites and/or develop new trial sites in sub-Saharan Africa for the conduct of regulatory-standard vaccine trials.

EDCTP considers that proposals requesting a contribution from the EDCTP2 of between EUR 5 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.

EDCTP considers that proposals of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals for activities of a different duration.

Expected impact
Proposals that leverage major relevant financial contributions from funders other than the EDCTP Association will be considered to have a higher impact.

Projects funded under this Call for Proposals should:

• contribute to the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’
• contribute towards the reduction of the burden of diarrhoeal diseases or lower respiratory tract infections in sub-Saharan Africa
• lead to the advancement of vaccine candidates along the product development pipeline.

Eligibility
A proposal 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 set out below, depending on the type of action:
   • Consortia comprising a minimum of three independent legal entities are eligible to apply. 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 shall 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

* Europe
The following European countries are EDCTP Participating States: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden and United Kingdom.

** Sub-Saharan Africa
The following African countries are eligible: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Ethiopia, 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, Zimbabwe.

Procedure and application process

Submission and evaluation procedure
This is a single-stage application procedure. Proposals must be submitted by 30 October 2018 at 17:00 CET via EDCTPgrants. Evaluation results are expected to be made available by 14 March 2019.

Evaluation, scoring and thresholds
Following an admissibility and eligibility check, letters of intent and full proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria Excellence, Impact and Implementation. Each criterion is scored between 0 and 5.

The following aspects are considered under the evaluation criteria:

1. Excellence
The following aspects will be taken into account, to the extent that the proposed work corresponds to the topic description in the work plan:

• Fit with the scope and objectives of the EDCTP2 Programme, the EDCTP 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 that 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.

2. Impact

The following aspects will be taken into account:

• 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
• 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, 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

The following aspects will be taken into account:

• Quality and effectiveness of the work plan, including 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 time frame 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).

The Coordinator has a ‘right to reply’ to the expert assessments (rebuttal procedure).

Financial provisions
The call budget is EUR 23 million.

EDCTP considers that proposals requesting a contribution from the EDCTP2 of between EUR 5 and 10 million would allow this specific challenge to be addressed appropriately. The funding level is 100% of eligible costs.

Grant agreement
The Coordinator is required to sign a grant agreement with EDCTP (EDCTP2 multi-beneficiary grant agreement) within three months of receipt of the evaluation outcome letter. All participants in the action must sign a consortium agreement prior to signature of the grant agreement.

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.

Documents & info

Documents

• Template of application form – Full Application (Word)
• Template for essential information to be provided for proposals including clinical studies (Word)
• Guidance for applicants on preparing full proposals and annex 1 of the grant agreement (PDF)
• Call-specific FAQs (PDF)

More information

• For questions about this call for proposals, please contact: Dr Michelle Helinski at helinski@edctp.org
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants@edctp.org
• For guidance on online application procedure, please refer to the Guidance for applicants
• For more information about EDCTP2 procedures, please refer to the EDCTP2 Grants Manual (PDF) and EDCTP2 FAQs
• EDCTP2 policy on clinical trials registration, publication and data sharing (PDF)
• Global Code of Conduct for Research in Resource-Poor Settings (PDF)

Projects awarded under this call

ETEC ETVAX
First ETEC vaccine

Scandinavian Biopharma Holding AB (SBH), Solna, Sweden, with partners in Finland, Sweden and Zambia.
Project coordinator: Mr Björn Sjöstrand (SBH)
Starting date: 01 March 2020
Duration: 60 months
EDCTP grant amount: EUR 10,552,499
Grant agreement: RIA2018V-2309

PREPARE
Prevention of invasive Group B Streptococcus disease in young infants: a pathway for the evaluation & licensure of an investigational maternal GBS vaccine

St George’s Hospital Medical School (SGUL), London, United Kingdom, with partners in Denmark, France, Italy, the Netherlands, South Africa, Uganda, the United Kingdom, and the United States of America.
Project coordinator: Dr Kirsty Le Doare
Starting date: 01 October 2019
Duration: 60 months
EDCTP grant amount: EUR 9,995,744
Grant agreement: RIA2018V-2304

ShigOraVax
Early clinical development of an oral Shigella vaccine through phase II study in Africa

European Vaccine Initiative EWIV (EVI), Heidelberg, Germany, with partners in Burkina Faso, India, the Netherlands, Sweden, and Zambia
Project coordinator: Dr Hilde Depraetere (EVI, Germany)
Starting date: 01 October 2019
Duration: 60 months
EDCTP grant amount: EUR 8,604,333
Grant agreement: RIA2018V-2308
Project website