Advances in product development for effective prevention, treatment and management of co-infections and co-morbidities – 2018

Description

Challenge
Co-infections with several pathogens are frequent in sub-Saharan Africa and represent an important public health problem in many areas due to accelerated and/or complicated disease progression, resulting in increased mortality and morbidity. These co-infections can result in unique challenges in treatment and prevention of disease, including increased drug toxicities and/or changes in efficacy of interventions. The rise in incidence of non-communicable diseases (NCDs) in sub-Saharan Africa and the necessity for long-term management of some poverty-related diseases and NCDs, often concurrently, adds to these complexities. There is therefore an urgent need for research that leads to advances in the development of new/improved products for the effective prevention, treatment and management of co-infections and co-morbidities.

Scope
The purpose of this Call for Proposals is to support actions that lead to improvements in  the prevention, treatment and/or clinical management of co-infections and co-morbidities in sub-Saharan Africa. Proposals must include at least one infection within the EDCTP2 scope*. Proposals on co-infections and co-morbidities other than those involving HIV/AIDS are also encouraged.

Consortia should incorporate the latest innovations and advances in trial design and research methods in order to evaluate promising interventions. Proposals should include one or more clinical trial(s) to be conducted in sub-Saharan Africa. 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.

Stand-alone epidemiological studies are outside the scope of this call. Proposals on diagnostics are also outside the scope of this call, but may be relevant for the separate call under this annual work plan on “Diagnostic tools for poverty-related diseases”.

EDCTP considers that proposals requesting a contribution from the EDCTP2 of between EUR 2.0 and 4.0 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 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
Projects funded under this Call for Proposals should:

• contribute towards the reduction of the number of cases of co-infections and co-morbidities in sub-Saharan Africa and thus contribute to achieving SDG 3 ‘Ensure healthy lives and promote well-being for all at all ages
• advance products through the product development pipeline, and/or provide evidence to support label extension and/or be in line with EDCTP2’s strategic research agenda to be considered as having a higher impact.

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

* In the EDCTP2 programme, “poverty-related diseases (PRDs)” include HIV/AIDS, malaria, tuberculosis and the following neglected infectious diseases (NIDs): dengue/severe dengue; rabies; human African trypanosomiasis (sleeping sickness); leishmaniases; cysticercosis/taeniasis; dracunculiasis (guinea-worm disease); echinococosis; foodborne trematodiases; lymphatic filariasis; mycetoma; 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 Ebola or yellow fever.

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

*** 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 call has a two-stage application procedure.  For the first stage, a letter of intent must be submitted by the first deadline. Successful applicants in the first stage will be invited to submit a full proposal for the second stage.

• Proposals for Stage 1 must be submitted by 18 October 2018 at 17:00:00 CET via EDCTPgrants. Evaluation results for Stage 1 are expected to be made available by 21 December 2018.
• Proposals for Stage 2 must be submitted by 28 March 2019 at 17:00:00 CET via EDCTPgrants. Evaluation results for Stage 2 are expected to be made available by 25 July 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.

For the evaluation of first-stage proposals under a two-stage submission procedure, only the criteria ‘excellence’ and ‘impact’ will be 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 2 is as close as possible to three times the available budget, and in any case, not less than two and a half 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.

For the evaluation of first-stage proposals under a two-stage submission procedure, an arithmetic average (mean value) or median of the individual scores may be taken as the consensus score. The consensus report may consist of a collation of the individual evaluation reports or extracts from them.  As part of the evaluation, a review committee may be convened to reach consensus on the applications proceeding to the second stage.

The Coordinator has a ‘right to reply’ to the expert assessments (rebuttal procedure) at the second-stage evaluation.

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 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)

Financial provisions
The call budget is EUR 14 million.

The EDCTP considers that proposals requesting a contribution from the EDCTP2 of between EUR 2.0 and 4.0 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

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 Proposal for stage 1 – Letter of Intent – (Word)
• Template for Proposal for stage 2 – Full Application (Word)
• Guidance for applicants on preparing full proposals and annex 1 of the grant agreement (PDF)
• Template for essential information to be provided for proposals including clinical studies (Word)

More information

• For questions related to this call for proposals, please contact: Johanna Roth at roth@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

5FC HIV-Crypto
Improved flucytosine formulation for the treatment of meningitis in advanced HIV disease

Drugs for Neglected Diseases Initiative (DNDi), Geneva, Switzerland, with partners from Luxembourg, Malawi, South Africa, Tanzania, and the United Kingdom
Project coordinator: Dr Isabela Ribeiro
Starting date: 01 July 2020
Duration: 54 months
EDCTP grant amount: EUR 3,537,000
Grant agreement: RIA2018CO-2516

DATURA
Determination of adequate tuberculosis regimen in adults and adolescents hospitalised with severe HIV-associated severe immune suppression (CD4 ≤ cells/𝝁L)

Institut national de la santé et de la recherche médicale (INSERM). Paris, France, with partners from Cameroon, France, Guinea, Norway, and Zambia
Project coordinator: Dr Didier Laureillard
Starting date: 01 May 2020
Duration: 54 months
EDCTP grant amount: EUR 4,567,140
Grant agreement: RIA2018CO-2515

META TRIAL
Preventing and delaying the development of diabetes in Africa: a randomised placebo-controlled double-blind phase III trial of metformin in HIV-infected persons with pre-diabetes

Liverpool School of Tropical Medicine (LSTM), Liverpool, United Kingdom, with partners from Norway, Spain, and Tanzania
Project coordinator: Prof. Shabbar Jaffar (LSTM)
Starting date: 01 April 2020
Duration: 57 months
EDCTP grant amount: EUR 3,992,974
Grant agreement: RIA2018CO-2513

PROTID
Randomised controlled trial of preventive treatment of latent tuberculosis infection in patients with diabetes melittus

Stichting Katholieke Universiteit  – Radboudumc (RUMC), Nijmegen, the Netherlands, with partners from New Zealand, Tanzania, Uganda, and the United Kingdom
Project coordinator: Dr Reinout van Crevel (RUMC)
Starting date: 01 January 2020
Duration: 54 months
EDCTP grant amount: EUR 4,844,699
Grant agreement: RIA2018CO-2514
Project website

VITALITY
Vitamin D for adolescents with HIV to reduce musculoskeletal morbidity and immunopathology: an individually randomised, double-blinded, placebo-controlled trial

London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom, with partners from Germany, the United Kingdom, Zambia, and Zimbabwe
Project coordinator: Prof. Rashida Ferrand (LSHTM)
Starting date: 01 January 2020
Duration: 60 months
EDCTP grant amount: EUR 3,943,982
Grant agreement: RIA2018CO-2512