Description

Background
Vaccines have contributed enormously to the successful control and elimination of many diseases. To date, few vaccines have been developed for controlling poverty-related diseases (PRDs)(1). In recent years, several candidate vaccines against PRDs have entered clinical development and there is an urgent need to fast track their development. The aim is to increase the number of promising vaccines targeted for use especially in Africa.

Scope
Applications are invited for large-scale collaborative projects which include one or more clinical trials (phase I to IV) aiming to accelerate the clinical development of new vaccines (preventive or therapeutic) against one of the PRDs. Applications must include at least one clinical trial which will be carried out in sub-Saharan Africa to test the safety, immunogenicity and/or efficacy of the vaccine(s).

Target product profiles, particularly indication, target populations, safety and/or efficacy should be included. Additionally, a clear list of product development milestones including specific go/no-go criteria for the implementation of the proposed clinical trial must be included.

Projects may include detailed analyses of host responses to advance the understanding of mechanisms of reactogenicity (safety), immunogenicity and/or efficacy. Projects should incorporate activities to enhance the capacity of existing trial sites and/or develop new trial sites in sub-Saharan Africa for conduct of vaccine trials.

Applications that leverage support from other funders, particularly the pharmaceutical industry and Product Development Partnerships, are encouraged.

EDCTP considers that proposals for actions 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 actions of a different duration.

Expected impact
Actions supported under this Call for Proposal should advance the development of promising candidate vaccines for PRDs moving towards regulatory licensure. The actions should also contribute towards a better understanding of the mechanisms of reactogenicity (safety), immunogenicity and/or efficacy profile of the vaccine candidate(s). The projects will build capacity for the evaluation of different vaccines against PRDs in sub-Saharan Africa.

Eligibility
Consortia comprising a minimum of three independent legal entities are eligible to apply. Two of the legal entities must be established in two different European Participating States(2) of the EDCTP Association and one of the legal entities must be established in a sub-Saharan African country(3).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

1. For the purpose of this call, PRDs include: HIV, malaria, tuberculosis, and also the following neglected infectious diseases (NIDs): dengue/severe dengue; rabies; human African trypanosomiasis (sleeping sickness); Leishmaniases; cysticercosis/taeniasis; dracunculiasis (guinea-worm disease); echinococcosis; food-borne trematodiases; lymphatic filariasis; onchocerciasis (river blindness); schistosomiasis; soil-transmitted helminthiases; Buruli ulcer; leprosy (Hansen disease); trachoma; yaws; diarrhoeal infections; lower respiratory infections; as well as emerging infectious diseases of particular relevance for Africa, such as yellow fever. Ebola Virus Disease vaccine development is specifically excluded from this call since it has already been extensively funded by other parts of the Horizon 2020 programme.
2. Legal entities in the following European countries: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.
   3. Legal entities in the following sub-Saharan African countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Republic of Congo, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé & Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Sudan, South Africa, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

Procedure and application process

Submission and evaluation procedure

This is a two-stage application procedure. For the first stage, a letter of intent must be submitted by 13 October 2016 via EDCTPgrants. Applicants will be notified of the first-stage outcome by 22 December 2016. Successful applicants in the first stage will be invited to submit a full proposal. The indicative deadline for submission of full proposals is 16 March 2017.

Evaluation criteria, 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.

Stage 1: Letters of Intent
For the evaluation of the first stage (Letters of Intent), only the criteria Excellence and Impact are evaluated. Within these criteria, only the aspects in bold will be considered. The threshold for both individual criteria will be 4. The overall threshold, applying to the sum of the two individual scores, will be set at the level such that the total requested budget of proposals admitted to stage two is as close as possible to three times the available budget. The actual level will therefore depend on the volume of proposals and funding request per proposal received. The threshold is expected to normally be set at 8 or 8.5. Successful applicants will be invited to submit a full proposal in the second stage.

Stage 2: Full proposals
For the evaluation of the second stage (Full Proposals), evaluation scores will be awarded for the criteria Excellence, Impact and Implementation. Each criterion is scored between 0 and 5. The threshold for individual criteria is 3 and the overall threshold for the sum of the three individual scores is 10. Applicants have the opportunity to submit a written response to the expert reviewers’ comments prior to an expert review committee meeting convened by EDCTP to finalise the funding recommendations.

The following aspects are considered under the evaluation criteria:

1. Excellence

• Fit with the scope and objectives of the EDCTP2 programme 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) 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 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 for 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 where relevant.

3. Quality and efficiency of the implementation

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

Financial provisions
The call budget is 70 million EUR.

The requested EDCTP contribution per action should not exceed 15 million EUR. 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 conditional award letter. All participants in the action must sign a consortium 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 and more information

Documents

• EDCTP2 annual work plan 2016 (PDF)
• Template of application form – Letter of Intent (Word)
• Template of application form – Full Application (Word)
• Annex: Essential information for clinical trials applications (PDF)

More information

• For questions related to this call for proposals, please contact: Dr Michelle Helinski at helinski[at]edctp.org.
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants[at]edctp.org or +31 (0) 70 344 08 80.
• 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
• Call-specific FAQs (PDF)

Projects awarded under this call

MMVC
Multi-stage malaria vaccine consortium: field efficacy testing of a multi-stage malaria vaccine

Chancellor, Masters and Scholars of the University of Oxford (UOXF) with partners from Burkina Faso, France, Germany, India, Netherlands, Sierra Leone, Sweden, Tanzania, and United Kingdom
Project coordinator: Prof. Adrian V.S. Hill, Nuffield Department of Medicine (UOXF), United Kingdom
Starting date: 1 April 2018
Duration: 66 months
Grant amount: EUR 15,000,000
Grant agreement: RIA2016V-1649
ERA-Learn project webpage

MTBVAC-Newborns
MTBVAC in Newborns: Phase 2a dose-defining safety and immunogenicity study and capacity building to support vaccine efficacy trials in tuberculosis-endemic regions of sub-Saharan Africa

Biofabri S.L., Pontevedra, Spain with partners from Madagascar, Netherlands, Senegal, South Africa, Spain
Project coordinator: Ms Ingrid Murillo, Biofabri S.L., Spain
Starting date: 1 January 2018
Duration: 52 months
Grant amount: EUR 5,537,093
Grant agreement: RIA2016V-1637
Project web page on TBVI website

NIFTY
Non-inferiority of fractional-doses trial for yellow fever vaccine

Chancellor, Masters and Scholars of the University of Oxford (UOXF) with partners from France, Senegal,and Uganda
Project coordinator: Prof. Philip Bejon (UOXF), KEMRI-Wellcome, Kenya
Starting date: 1 April 2018
Duration: 40 months
Grant amount: EUR 3,235,731
Grant agreement: RIA2016V-1633

POR TB
POR TB consortium: phase 2 trial to determine efficacy of the multistage vaccine H56:IC31 for prevention of recurrent TB disease

Statens Serum Institut (SSI), Copenhagen, Denmark with partners from Italy, South Africa, and Tanzania
Project coordinator: Prof. Peter L. Andersen, Statens Serum Institut, Copenhagen, Denmark
Starting date: 01 November 2017
Duration: 60 months
Grant amount: EUR 13,788,161
Grant agreement: RIA2016V-1631
Project website

PrEPVacc
A combination effect study in Africa of two DNA-MVA- or DNA- Env protein HIV-1 vaccine regimens with pre-exposure prophylaxis (PrEP)

Imperial College of Science, Technology and Medicine (Imperial College), London, United Kingdom with partners from Germany, Sweden, Mozambique, South Africa, Switzerland, Tanzania, Uganda, United Kingdom, and United States
Project coordinator: Prof. Jonathan Weber, Imperial College, United Kingdom
Starting date: 1 January 2018
Duration: 63 months
Grant amount: EUR 14,999,955
Grant agreement: RIA2016V-1644
See also the AVAC web page or the ERA LEARN web page

PREV-PKDL
Clinical development of a therapeutic vaccine for prevention of post-kala azar dermal leishmaniasis

European Vaccine Initiative – EWIV (EVI), Heidelberg, Germany with partners from Ethiopia, Kenya, Sudan, Uganda, and United Kingdom
Project coordinator: Dr Sophie Houard, EVI, Germany
Starting date: 1 April 2018
Duration: 63 months
Grant amount: EUR 8,000,476
Grant agreement: RIA2016V-1640
Project website

priMe
A multicentre phase III double-blind, randomised, controlled study to evaluate the efficacy and safety of VPM1002 in comparison to BCG

Vakzine Projekt Management GmbH (VPM), Hannover, Germany with partners from Gabon, India, Kenya, the Netherlands, South Africa, Tanzania, and Uganda
Project coordinator: Dr Leander Grode, VPM, Germany
Starting date: 1 May 2018
Duration: 60 months
Grant amount: EUR 12,492,521
Grant agreement: RIA2016V-1645
Project website