Developing novel, innovative HIV therapeutics for reducing the disease burden of HIV in sub-Saharan Africa
European Comission
ExpectedOutcome :
This topic aims at supporting activities that contribute to one or several of the expected impacts for this call. To that end, proposals submitted under this topic should aim for delivering results that are directed, tailored towards and contributing to at least two of the following expected outcomes:
- Evidence of efficacy, safety and clinical utility for health care professionals and clinicians in sub-Saharan Africa about novel, targeted HIV therapeutics that improve treatment outcomes and quality of life;
- Innovative HIV therapeutics that have demonstrated meaningful advances over existing therapeutic interventions for patients living with HIV in terms of their ability to improve efficacy, safety, adherence, quality of life and reduce HIV-associated mortality and morbidity.
- Public health authorities and policy makers have information from comprehensive clinical trial data on the overall health effects of novel therapeutic HIV interventions, helping them to draft updated or new evidence-based clinical guidelines and best practices as well as design tailor-made HIV policies. Scope :
Background:
Over the last few decades, antiretroviral therapy has dramatically increased the life expectancy of HIV patients, turning HIV from a death sentence into a chronic illness. Nevertheless, there are currently around 39 million infected people around the globe and HIV remains a major cause of death, disability and ill-health. The HIV disease burden continues to be high in sub-Saharan Africa, in particular for children and adolescents, and those with co-morbidities. There is therefore a strong need to achieve the 2030 UNAIDS 95-95-95 target[1] (95% of people with HIV know their HIV status; 95% of people with diagnosed HIV infection receive antiretroviral therapy; 95% of people receiving antiretroviral therapy have effective viral suppression) and develop novel HIV therapeutics, novel clinical delivery modes for their administration and novel biomarkers for optimising treatment decisions.
Scope:
Accordingly, the proposed research must deliver on the following:
- Carry out advanced stage clinical trials of promising HIV therapeutic interventions, for example but not limited to broadly neutralising antibodies, long-acting antiretrovirals or gene therapy approaches.
It may additionally also include:
- Creation and testing of novel clinical delivery routes for the administration of HIV therapeutic interventions that bring meaningful benefit for HIV patients in terms of safety, efficacy, adherence and quality of life;
- In the context of the planned clinical investigations, identification and validation of biomarkers for better optimisation and personalisation of HIV treatment decisions as well as more accurate predictors of progression towards AIDS.
Applicants need to concisely describe any prior research findings and explain how the proposal builds on these results.
Proposals must carry out late-stage clinical research. Implementation research is not in scope for this topic. The research to be conducted must be inclusive and involve vulnerable groups, in particular infants, children and adolescents. Applicants are further encouraged to involve populations with limited clinical trial data, as well as HIV patients with co-infections and co-morbidities, both of which are associated with polypharmacy and present a serious risk for drug-drug interactions. Sex and gender differences and the effects of age should be duly taken into account.
Proposals should engage all relevant stakeholders, most notably researchers, health care professionals, policy makers, public health authorities and end-users. Applicants should provide methodologies for translating research findings into public health practice and policy guidelines.
Where possible, collaboration and coordination with the Team Europe Initiative on Manufacturing and Access to Vaccines, medicines and health products (TEI-MAV+) is encouraged. The applicants could show, for example, willingness to enter into technology transfer agreements with African counterparts - including the provision of patents, technical knowledge and know-how -, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market.
Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from sub-Saharan African countries, including involvement of Franco/Lusophone countries if possible. Collaboration with other international research groups developing HIV therapeutics is very much encouraged. Applicants are also reminded of the expectation of reaching out to organisations in countries with relatively lower research capacities.
[1] Joint United Nations Programme on HIV/AIDS (UNAIDS). (2014). Fast-Track: ending the AIDS epidemic by 2030. https://www.unaids.org/sites/default/files/media_asset/JC2686_WAD2014report_en.pdf
Expected Impact :
Activities funded under the 2024 work programme of the Global Health EDCTP3 JU calls for proposals should contribute to:
- reduce the individual, social, and economic burdens of infectious diseases in sub-Saharan Africa through the development and uptake of new or improved interventions, and
- increase health security in sub-Saharan Africa and globally by reducing the risk of outbreaks and pandemics and enhancing national and regional capacity to address antimicrobial resistance.
- Progressing towards the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African (SSA) countries;
- Enable the implementation of the short- and medium-term actions foreseen by the AU EU Innovation Agenda (adopted in July 2023) in the area of public health and the EU Global Health Strategy (November 2022);
- Improve equitable access to a full range of essential health services from health promotion to disease prevention and affordable quality treatment, rehabilitation and palliative care to fight communicable diseases;
- Expand partnerships based on equal footing, co-ownership, mutual interest and strategic priorities;
- Provide evidence for informed health policies and guidelines within public health systems in SSA and at international level;
- Enhance sustainable global scientific collaboration in health research and international cooperation across SSA;
- Develop novel, innovative HIV therapeutics for reducing the disease burden of HIV in SSA
- Research on existing Malaria vaccines and development of new promising candidates
- Accelerating development and integration of therapeutics against neglected tropical diseases (NTDs) in SSA;
- Tackle Antimicrobial Resistance (AMR) through R&D in novel and existing antimicrobials
- Develop new tools, technologies and approaches for vector control in SSA;
- Develop innovative digital health solutions for SSA.
- Build appropriate local capacity.
General conditions
- Admissibility conditions: described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes
Proposal page limits and layout: described in Part B of the Application Form available in the Submission System
- Eligible countries: described in Annex B of the Work Programme General Annexes
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide .
- Other eligibility conditions: described in Annex B of the Work Programme General Annexes
Replacing relevant sections in General Annex B to the Horizon Europe work programmes on eligibility (“Entities eligible for funding”)
To become a beneficiary, legal entities must be eligible for funding.
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, New Zealand (associated to Pillar II 'Global Challenges and European Industrial Competitiveness' as from the Work Programmes 2023 onwards, including for the institutionalised European partnerships), North Macedonia, Norway, Serbia, Tunisia, Turkey, Ukraine, United Kingdom.
Until association agreements start producing legal effects either through provisional application or their entry into force, transitional arrangements apply. The transitional arrangements apply, at the time of the adoption of this Work Programme, with regard to the following countries and legal entities established in these countries, with which association negotiations are being processed or where association is imminent):
Canada
Morocco
- The following countries which are constituent states of the EDCTP Association [3]: Benin, Burkina Faso, Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Gabon, The Gambia, Ghana, Guinea-Bissau, Guinea-Conakry, Kenya, Liberia, Malawi, Mali, Mozambique, Niger, Nigeria, Republic of the Congo, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, Tanzania, Uganda, Zambia, Zimbabwe.
Consortium composition
Unless otherwise provided for in the specific call conditions, for all actions, due to the policy objectives of the Global Health 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 independent from each other and 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.
This condition applies to both Research and Innovation Actions (RIA) and Coordination and Support Actions (CSA).
Specific cases:
Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary[4] which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
Associated partners — Entities not eligible for funding (and therefore not able to participate as beneficiaries) may participate as associated partners, unless specified otherwise in the specific call conditions.
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 regarding legal entities that may be the coordinator of an indirect action
In accordance with Article 110(2) 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 must 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 at the moment.[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 Global Health EDCTP3 JU regarding all scientific action governance issues, steer and provide oversight in the development of the scientific actions, without prejudice to the tasks 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 Global Health 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.
[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] 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
[4] See Article 187 EU Financial Regulation 2018/1046.
[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
Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes
Evaluation and award:
- Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes
Replacing the scores and weighting section in General Annex D to the Horizon Europe work programmes as regards Research and Innovation Actions (RIA) second stage of two-stage evaluations.
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.
Nota bene, for the first stage of the two-stage evaluation, the scores and weighting as indicated in Annex D of the General Annexes of the Horizon Europe work programme 2023/2024 apply. Furthermore, the scores and weighting for Coordination and Support Actions apply.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes
- Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes
Also in line with Article 114 of the Council Regulation 2021/2085, participants will be subject to the following additional exploitation obligations:
- 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.
- 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.
- 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.
- 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.
Implementing the provision on affordable access as defined in Article 114 of the Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe[1], grants awarded under this topic will have to submit the following deliverables:
- Stewardship plan
Participants 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.
- Global access plan
With the final report, participants 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.
[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
Specific conditions
- Specific conditions: described in the [specific topic of the Work Programme]
Documents
Call documents:
Standard application form — call-specific application form is available in the Submission System
Standard application form (HE RIA, IA)
Standard application form (HE RIA IA Stage 1)
Standard evaluation form — will be used with the necessary adaptations
Standard evaluation form (HE RIA, IA)
Standard evaluation form (HE RIA, IA and CSA Stage 1)
MGA
Call-specific instructions
Information on clinical studies (HE)
Additional documents:
GH EDCTP3 - WP 2024 Annex1A - Calls for Proposals
GH EDCTP3 - WP 2024 Annex1B - IKAA
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