Developing novel, innovative HIV therapeutics for reducing the disease burden of HIV in sub-Saharan Africa
Programme Category
Programme Name
Programme Description
The Global Health EDCTP3 Joint Undertaking (GH EDCTP3) builds on the first and second European and Developing Countries Clinical Trials Partnership programmes. This new joint undertaking (JU) is a partnership between the EU and the EDCTP Association, whose members are several European and African countries. The partnership will deliver new solutions for reducing the burden of infectious diseases in SSA and strengthen research capacities to prepare and respond to re-emerging infectious diseases in this region and across the world.
Identifier Code
Call
Summary
There is a strong need to achieve the 2030 UNAIDS 95-95-95 target and develop novel HIV therapeutics, novel clinical delivery modes for their administration and novel biomarkers for optimising treatment decisions in sub-Saharan Africa.
Detailed Call Description
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.
Call Total Budget
Financing percentage by EU or other bodies / Level of Subsidy or Loan
Expected EU Contribution per project: €5.500.000
Thematic Categories
- Health
- Research, Technological Development and Innovation
Eligibility for Participation
- Central Government
- International Organisations
- Legal Entities
- Other Beneficiaries
- Researchers/Research Centers/Institutions
- State-owned Enterprises
Eligibility For Participation Notes
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.
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: Albania, Armenia, Bosnia and Herzegovina, Faroe Islands, Georgia, Iceland, Israel, Kosovo, 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.
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):
1. Canada
2. Morocco
- The following countries which are constituent states of the EDCTP Association: 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.
Specific cases:
Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary 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.
Call Opening Date
Call Closing Date
EU Contact Point
EDCTP – Europe Office
Postal and visiting address: Anna van Saksenlaan 51, 2593 HW The Hague, The Netherlands
Telephone: +31 70 344 0880
EDCTP – Africa Office
Postal address: P.O. Box 19070, Tygerberg 7505, Cape Town, South Africa
Visiting address: Francie van Zijl Drive, Parowvallei 7505, Cape Town, South Africa
Telephone: +27 21 938 0690
Fax: +27 21 938 0569
Contact Form in the website