Funding to successfully finalise EDCTP2-funded clinical trials that were negatively impacted by the COVID-19 pandemic
HORIZON JU Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-JU-GH-EDCTP3-2023-01-02
- Programme
- HORIZON-JU-GH-EDCTP3-2023-01
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- May 10, 2023
- Deadline
- July 4, 2023
- Deadline Model
- single-stage
- Budget
- €15,300,000
- Min Grant Amount
- €5,000,000
- Max Grant Amount
- €5,000,000
- Expected Number of Grants
- 3
- Keywords
- HORIZON-JU-GH-EDCTP3-2023-01-02HORIZON-JU-GH-EDCTP3-2023-01Clinical researchClinical trialsGlobal healthInfectious diseasesPublic health
Description
Expected impacts of the calls under the 2023 work programme of the Global Health EDCTP3 JU
Activities funded under the 2023 calls for proposals should contribute to:
- Achieve SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African countries;
- Enable the implementation of the short and medium term actions foreseen by the AU EU Innovation Agenda[1] (expected to be adopted in June 2023) in the area of Public Health
- Provide evidence for informed health policies and guidelines within public health systems in sub-Saharan Africa and at international level;
- Strengthen clinical research capability in sub-Saharan Africa to rapidly respond to emerging epidemics;
- Enable a regulatory environment that can ensure effective development, delivery, and uptake of new or improved safe health technologies guaranteeing that trials in sub-Saharan African countries meet international standards;
- Increase cost effectiveness of public investment through collaboration of funders of clinical trials in the area of infectious diseases in sub-Saharan Africa;
- Strengthen health systems to ensure uptake of effective health technologies and innovations;
- Enhance sustainable global scientific collaboration in health research and international cooperation across sub-Saharan Africa.
- Improve opportunities for training of researchers and healthcare professionals in sub-Saharan Africa.
[1]Working document of the AU EU Innovation Agenda available online at: https://research-and-innovation.ec.europa.eu/system/files/2022-02/final_au-eu_ia_14_february.pdf
Expected Outcome:Project results are expected to contribute to the following outcomes:
- Clinical trials of medical technologies that were funded by EDCTP2 and whose activities were disrupted during the COVID-19 pandemic, can be concluded;
- Information about medical technologies can be used by health care professionals and health care systems.
The following clinical trials – identified by their clinical trial registration numbers - are addressed by this topic:
| ISRCTN[1] 61526229 PACTR[2]202010540737215 | Assessing the safety and tolerability of artemether-lumefantrine+atovaquone-proguanil tri-therapy for malaria treatment in adults and adolescents in Gabon |
| ISRCTN 14750348 PACTR 202201797112873 | A multicentre phase III trial to evaluate the safety, tolerability, and efficacy of a combination of three antimalaria drugs (artemether-lumefantrine+atovaquone-proguanil) versus two malaria drugs (artemether-lumefantrine) +placebo in African children aged 6-59months with an uncomplicated malaria infection |
| PACTR 202011812241529 | Efficacy and safety of pyronaridine-artesunate (Pyramax) for the treatment of falciparum malaria in African pregnant women |
| NCT[3] 03876262 PACTR 202004639229710 | Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis |
| NCT 04311671 PACTR 202003567524647 | Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas |
| NL7294 (NTR7503) https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7503 | Integrated skin screening and SDR-PEP administration for leprosy prevention: comparing the effectiveness and feasibility of a community-based intervention to a health centre-based intervention in Ethiopia, Mozambique, and Tanzania (PEP4LEP) |
| PACTR 202011804563392
| A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA) |
| NCT 05119426 | Effectiveness of a Typhoid Conjugate Vaccine in DRC (TyVECO) |
| NCT 05047315 | Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV (Stool4TB) |
| NCT 05048472 | East Africa Point of Care Viral Load Study (EAPoC-VL) |
| NCT 05175794 | Triage Test for All Oral DR-TB Regimen (TRiAD Study) |
| NCT 05317247 | Cough Audio Classification as a TB Triage Test (CAGE-TB) |
| NCT 04145258 | Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis (INTENSE-TBM) |
| NCT 04600167 | Preventive Treatment Of Latent Tuberculosis Infection In People With Diabetes Mellitus (PROTID) |
| ISRCTN 77382043 | Metformin treatment for diabetes prevention in Africa |
| NCT 04653948 | Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital (PREPARE) |
| NCT 04732026 | Serocorrelate of protection against GBS |
| NCT 04596878 | Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV |
| PACTR202208844472053 | Increasing the uptake of intermittent preventive treatment using sulfadoxine-pyrimethamine through seasonal malaria chemoprevention channel delivery |
| NCT05441410
| Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults (SPICY) |
| NCT04601714 | Baseline Cohort Malaria Morbidity Study (BLOOMy) |
| PACTR201909810587438 | Safety and efficacy of Dolutegravir and EFV400 for pregnant and breastfeeding women: a randomized non-inferiority clinical trial |
This funding will ensure that essential clinical trials working to deliver answers of immediate public health relevance in SSA can be concluded. Focussing funding to projects previously supported under the EDCTP2 programme is justified by the advanced stage ongoing studies have reached. It is also justified by ethical issues, such as fully validating the willingness of trial participants to take part in the clinical investigations.
The proposals need to address all of the following:
- Demonstrate the work performed so far, such as number of recruited trial participants, follow-up status as well as analyses to be performed;
- Explain the impact of COVID-19-related delays and disruption in relation to the trial timing (start, recruitment, follow-up period);
- Clearly explain the additional work to be carried out, with a comprehensive plan and budget to conclude the planned studies in a tight timeframe;
- Proposals should present a sound assessment of the feasibility of the planned clinical investigations. Realistic plans for recruiting and following up trial subjects must be presented and corroborated by demonstrated success from previous studies and/or the current study;
- Whilst it is acknowledged that the projects build on previous studies, the proposals should briefly recall the justification of the choice of populations to be enrolled into the trials and explain how they relate to the larger population;
It should also be explained how the full range of relevant determining characteristics (sex, gender, age, socio-economic status, etc.) is considered.
[2]Pan-African clinical trials registry https://pactr.samrc.ac.za/
[3]US National Library of Medicine clinical trial registry https://clinicaltrials.gov/
Eligibility & Conditions
General conditions
2. Eligible countries:
The conditions are described in General Annex B except for the specific conditions for GH EDCTP3 funding as regards Entities eligible for funding and Consortium composition, the specific issue of legal entities from which countries can be the coordinator and the obligation to designate a scientific project leader. Participation conditions related to Russia’s illegal invasion of Ukraine are also set out below.
Replacing relevant sections in General Annex B to the Horizon Europe work programmes on Eligibility
Entities eligible to participate
Given the illegal invasion of Ukraine by Russia and the involvement of Belarus, the currently context does not allow the implementation of the actions foreseen in this programme with legal entities established in Russia, Belarus, or in non-government-controlled territories of Ukraine. Therefore, such legal entities are not eligible to participate in any capacity. This criterion also applies in cases where the action involves financial support given by grant beneficiaries to third parties established in Russia, Belarus or in non-government-controlled territories of Ukraine (in accordance with Article 204 of the Financial Regulation No 2018/1046).
To be eligible for funding, applicants must be established in one of the following countries:
- The Member States of the European Union, including their outermost regions: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden;
- The Overseas Countries and Territories (OCTs) linked to the Member States: Aruba (NL), Bonaire (NL), Curação (NL), French Polynesia (FR), French Southern and Antarctic Territories (FR), Greenland (DK), New Caledonia (FR), Saba (NL), Saint Barthélemy (FR), Sint Eustatius (NL), Sint Maarten (NL), St. Pierre and Miquelon (FR), Wallis and Futuna Islands (FR);
- Countries associated to Horizon Europe[1]; Albania, Armenia, Bosnia and Herzegovina, Faroe Islands, Georgia, Iceland, Israel, Kosovo[2], Moldova, Montenegro, North Macedonia, Norway, Serbia, Tunisia, Turkey, Ukraine. Considering the Union’s interest to retain, in principle, relations with the countries associated to Horizon 2020, most third countries associated to Horizon 2020 are expected to be associated to Horizon Europe with an intention to secure uninterrupted continuity between Horizon 2020 and Horizon Europe. In addition, other third countries can also become associated to Horizon Europe during the programme. For the purposes of the eligibility conditions, applicants established in Horizon 2020 Associated Countries or in other third countries negotiating association to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement with the third country concerned applies at the time of signature of the grant agreement[3];
- The following low- and middle-income countries which are constituent states of the EDCTP Association[4]: Burkina Faso, Cameroon, Congo, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Kenya, Liberia, Malawi, Mali, Mozambique, Niger, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Uganda, Zambia, Zimbabwe.
Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call conditions, or if their participation is considered essential for implementing the action by the granting authority.
Consortium composition
Unless otherwise provided for in the specific call conditions, for all actions, due to the policy objectives of the GH EDCTP3 JU, legal entities forming a consortium are eligible to participate in actions under the programme provided that the consortium includes:
- At least three legal entities established in different countries, where legal entities are eligible to receive funding;
- At least one independent legal entity established in a Member State or an associated country; and
- At least one independent legal entity established in a sub-Saharan African (SSA) country that is a member of the EDCTP Association.
Specific cases:
Affiliated entities – Affiliated entities are eligible for funding if they are established in one of the countries listed above.
International organisations – International European research organisations are eligible to receive funding. Other international organisations are not eligible to receive funding unless their participation is considered essential for implementing the action by the granting authority. International organisations with headquarters in a Member State or associated country are eligible to receive funding when provided for in the specific call conditions.
Specific rules on which legal entities can be the coordinator of an indirect action
According to article 110 of the Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe[5], where entities established in a third country without an agreement to protect the financial interests of the Union participate with funding in an indirect action, the financial coordinator of the indirect action shall be established in a Member State or associated country. Of the SSA countries members of the EDCTP Association, only South Africa concluded such an agreement.[6]
Scientific project leader
If the coordinator is not established in a country in sub-Saharan Africa (SSA), the designation of a scientific project leader established in a SSA country member of the EDCTP Association with the roles as described below is mandatory. A work package on ‘scientific project leadership’ must be included in the proposals and budget needs to be provided for this activity.
The scientific project leader oversees the project scientific governance and leadership. For this purpose, proposals must include a work package where the details of scientific project leadership are laid down. The scientific project leader should indicatively perform the following tasks:
- During the call for proposals and selection process, coordinate meetings on and drafting of the full project proposal;
- Work with the coordinator and other beneficiaries on the drafting and negotiation of the consortium agreement and other legal agreements among the beneficiaries;
- Act as the key contact point for the GH EDCTP3 regarding all scientific action governance issues, steer and provide oversight in the development of the scientific actions, acting as the key contact point for the GH EDCTP3 JU for these matters including external communication, other than the ones entrusted directly to the coordinator as per the Model Grant Agreement;
- Support and collaborate with the coordinator on its monitoring activities and the adoption of appropriate internal measures, to ensure that beneficiaries are fulfilling their obligations regarding budget, timeline, deliverables, and scientific quality;
- Review the action’s deliverables and reports before their submission by the coordinator;
- Lead the work packages(s) related to the tasks of scientific project leadership.
Annex 1 to the grant agreement and the consortium agreement should address the relationship of the scientific project leader with the coordinator regarding their respective tasks, for example sharing of the information received from or sent to the GH EDCTP3 JU on all issues of interest for the proper scientific management of the action.
[1]The list is correct at the time of adoption of this work programme. Please see the Horizon Europe List of Participating Countries on the Funding & Tenders Portal for up-to-date information on the current list and on the position for Associated Countries. https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/list-3rd-country-participation_horizon-euratom_en.pdf
[2]This designation is without prejudice to positions on status and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.
[3]Association of New Zealand is expected to take effect during 2023.
[4]The list is correct at the time of adoption of this work programme. For an update, please check the EDCTP Association website www.edctp.org.
[5]Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014. OJ L 427, 30.11.2021, p. 17–119; https://eur-lex.europa.eu/eli/reg/2021/2085
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes
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Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes
Replacing relevant section in General Annex D to the Horizon Europe work programmes
Scores and weighting
Evaluation scores will be awarded for the criteria, and not for the different aspects listed in the table. For full applications, each criterion will be scored out of 5. The threshold for individual criteria 1 (Excellence) and 2 (Impact) will be 4 and for criteria 3 (Quality and efficiency of the implementation) will be 3. The overall threshold, applying to the sum of the three individual scores, will be 12.
Proposals that pass the individual threshold and the overall threshold will be considered for funding, within the limits of the available call budget. Other proposals will be rejected.
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Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual
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Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes
Implementing the provision on affordable access as defined in Article 114 of the Council Regulation 2021/2085 establishing the Joint Under-takings under Horizon Europe, grants awarded under this topic will have to submit the following deliverables:
1. Stewardship plan
Beneficiaries must prepare stewardship plans outlining how to achieve the optimal use of an intervention, including, for example, how to avoid irrational use, overuse, or abuse of health technologies (e.g., antimicrobials). A draft plan must be submitted after half the duration of the project has elapsed and a final plan must be submitted with the final report.
2. Global access plan
With the final report, beneficiaries must submit an appropriate and proportionate global access plan that covers registration targets, plans to meet demand, flexible approaches to IP and other strategies that reflect ability to pay and ensure that economic barriers to access are low.
Also in line with Article 114 of the Council Regulation 2021/2085, participants will be subject to the following additional exploitation obligations:
1. Participants must – up to four years after the end of the action (see Data Sheet, Point 1) – use their best efforts to ensure that resulting health technologies and services will be broadly available and accessible, as soon as possible and at fair and reasonable conditions. In this respect, if, despite a participants’ best efforts, the results are not exploited within one year after the end of the action, participants must (unless otherwise agreed in writing with the granting authority) use the Horizon Results Platform to find interested parties to exploit the results.
2. In case the participants cannot fulfil the preceding obligation, the participants must (if requested by the granting authority) grant non-exclusive licences - under fair and reasonable conditions - to their results to legal entities that commit to rapidly and broadly exploiting the resulting health technologies and services and ensure that they are broadly available and accessible, as soon as possible and at fair and reasonable conditions.
3. In case of transfer of the ownership or licensing of results, participants must pass on such additional exploitation obligations to the legal entities exploiting the results.
4. For up to four years after the action (see Data Sheet, Point 1), the funding body must be informed every year about the status of the development of the product and any other exploitation of the results through an annual report that is due on each anniversary of the end of the grant agreement.
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme
Only proposals addressing the clinical trials, listed by their registration number in a clinical trial registry in the topic description, can be selected for funding.
Scientific Project Leader
For all projects under this topic, if the coordinator is not established in a country in sub-Saharan Africa (SSA), the designation of a scientific project leader established in a SSA country member of the EDCTP Association with the roles as described in the introduction is mandatory. A work package on ‘scientific project leadership’ must be included in the proposals and budget needs to be provided for this activity.
Grant Conditions - EC objection to transfer of ownership to a third party in a third country
According to the Horizon Europe rules, and to protect Union interests, the right for the GH EDCTP3 to object to transfers of ownership of results or to grants of an exclusive licence regarding results should apply to participants. Therefore, the provisions set out in General Annex G to the Horizon Europe work programmes on the right to object apply generally. It should be noted that in accordance with the Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe[1] and the Model Grant Agreement, the right to object applies also to participants that have not received funding from the JU and for the periods set therein.
[1] Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014; OJ L 427, 30.11.2021, p. 17
Documents
Call documents:
Standard application form — call-specific application form is available in the Submission System
Standard application form (HE RIA, IA)
Standard evaluation form — will be used with the necessary adaptations
Standard evaluation form (HE RIA, IA)
MGA
Call-specific instructions
Additional documents:
Annex 2 - In-kind contributions (IKAA plan)
HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 13. General Annexes
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Support & Resources
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Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
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Latest Updates
EVALUATION RESULTS
Call Identifier: HORIZON-JU-GH-EDCTP3-2023-01
Published: 14/04/2023
Deadline: 04/07/2023
Available budget: 74.3 million EUR
The results of the evaluation are as follows
Number proposals submitted: 99
Number ineligible proposals: 8
Number of above-threshold: 46
Total budget requested for above-threshold proposals: 152.8 million EUR
Number of Main list: 25
Number of Reserve list: 8
Number of rejected proposals due to budgetary resources: 13
Number of proposal upgraded from Reserve list to Main list: 2
We recently informed the applicants about the evaluation results for their proposals.
For questions, please contact us at [email protected]
Call Single Stage HORIZON-JU-GH-EDCTP3-2023-01 closed on July 4th, 2023.
A total of 99 proposals were submitted.
The breakdown per topic is:
- HORIZON-JU-GH-EDCTP3-2023-01-01: 25 proposals
- HORIZON-JU-GH-EDCTP3-2023-01-02: 18 proposals
- HORIZON-JU-GH-EDCTP3-2023-01-03: 28 proposals
- HORIZON-JU-GH-EDCTP3-2023-01-04: 10 proposals
- HORIZON-JU-GH-EDCTP3-2023-01-05: 18 proposals
Evaluation results are expected to be communicated on Friday 24th October 2023 at the earliest.
The call deadline has been postponed to 04/07/2023