Strategic action for the comparison, selection and development of malaria vaccine candidates – 2018

Description

Background
An effective and affordable malaria vaccine would present a major tool towards the eradication of malaria. The recently licensed malaria vaccine for human use (RTS,S) is an important step in this direction, but it is crucial to develop new and more effective second generation vaccines superior to RTS,S. A number of promising second generation vaccine candidates are currently under clinical or advanced preclinical development. Clinical trials to support the product approval process are often large in scale, complex and prohibitively expensive for a single funder. Coordination and collaboration between partners and funders is therefore essential to leverage sufficient expertise, resources and investments for accelerating the development of new or improved products and maximise the impact of research investments.

Scope
The purpose of this Call for Proposals is to support one large-scale strategic action (clinical research activities) that is part of a bigger portfolio of clinical trials with the capacity to compare and select the most promising malaria vaccine candidates, and manage their progress through clinical development. This should be achieved by establishing an objective set of stage-gate criteria that can be used for comparing and evaluating a diverse set of vaccine candidates developed by different research groups, with the aim of bringing them together in a joint portfolio.

Proposals should include one or more clinical trials (phase I to III), and may also include detailed analyses of host responses to advance the understanding of mechanisms of reactogenicity (safety), immunogenicity and/or efficacy. The consortium should incorporate the latest innovations and advances in clinical trial design and research methods in order to accelerate vaccine development, achieve rapid results, reduce subject number and ensure cost-effective use of available resources.

Proposals should include details of the target product profile for the vaccine candidate making reference to the Malaria Vaccine Technology Roadmap and to the WHO Preferred Product Characteristics for Malaria Vaccines , including details of the indication, target populations, desired safety and efficacy. The product profile should have the ambition of selecting vaccine candidates with a superior safety and efficacy profile, as demonstrated through published clinical study reports or publications, in comparison with the existing RTS,S vaccine.

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 proposed study(ies) should be conducted in sub-Saharan Africa but may form part of larger trial that is conducted globally. 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. Furthermore, the proposal must clearly document the consortium’s proven capacity to bring a medicinal product to market.

Proposals are expected to incorporate activities to enhance the capacity of existing clinical trial sites and/or develop new trial sites in sub-Saharan Africa for the conduct of vaccine trials. Successful applicants will be requested to coordinate their activities with other ongoing EDCTP and H2020 funded actions of relevance to malaria vaccine development.

Proposals for a strategic action must also present the broader description of the portfolio of clinical trials/studies in their entirety, including details of the trial(s) for which EDCTP funding is requested and the component(s) that are to be financed from other sources. Proposals should make a clear distinction between the broader context of the portfolio of studies as opposed to the proposed action itself (i.e. the specific clinical trials or part of trial to be funded as a strategic action by the EDCTP Association). The portfolio must be of a sufficient scale and ambition to justify EDCTP support in combination with financial support from other funders, such as EDCTP2 Participating States and/or third parties. The maximum amount requested from EDCTP Association shall not exceed EUR 18 million to be matched by an equal or greater financial contribution from other funders. EDCTP considers that proposals with a total cost of between EUR 20 and 40 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 for activities of between 48 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.

The action funded under this Call for Proposals should contribute to increased international cooperation among researchers and funders, catalyse research synergies, and leverage resources and investments in order to compare multiple vaccine candidates and achieve rapid advances in the development of new malaria vaccines. Proposals that leverage major relevant financial contributions from funders other than the EDCTP Association will be considered to have a higher impact.

The large-scale strategic action should have the potential to achieve maximum impact in the field and to make a significant contribution to the objectives of the EDCTP2 programme. In particular, the large-scale, strategic action should:

• lead to the advancement of vaccine candidates through the development pipeline towards registration, leading to more effective prevention and clinical management of malaria in sub-Saharan Africa
• contribute to the reduction of malaria mortality and morbidity in sub-Saharan Africa and thus contribute to achieving SDG 3 ‘Ensure healthy lives and promote well-being for all at all ages’

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 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 1 November 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 fulfill 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 18 million.

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 related to 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 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

MIMVaC Africa
A multilateral initiative to foster the clinical development of effective malaria vaccine candidates in Africa

Groupe de Recherche Action en Santé (GRAS), Ouagadougou, Burkina Faso, with partners in Gabon, Germany, Japan, Luxembourg, Mozambique, the Netherlands, Tanzania, and the United Kingdom.
Project coordinator: Dr Sodiomon Sirima (GRAS)
Starting date: 01  February 2020
Duration: 60 months
EDCTP grant amount: EUR 11,909,000
Grant agreement: RIA2018SV-2310
Project website

PfTBV
Rapid evaluation of Plasmodium falciparum transmission-blocking vaccine (PfTBV) candidates through enhanced African resource centres (ARC) for integration into malaria control and elimination

Université des Science, des Techniques et des Technologies de Bamako (USTTB), Bamako, Mali, with partners in Burkina Faso, Denmark, Guinea, Liberia, the Netherlands, and the United States of America.
Project coordinator: Dr Issaka Sagara (USTTB)
Starting date: 01 January 2019
Duration: 68 months
EDCTP grant amount: EUR 17,999,992
Grant agreement: RIA2018SV-2311