DENSTAR: Dengue efficacy and Safety Trial in African Region
| DENSTAR facts | |
| TOPIC: | HORIZON-JU-GH-EDCTP3-2025-01-NTD-03-two-stage |
| MAXIMUM GRANT AMOUNT: | € 11 091 138.75 |
| DURATION: | 4 years (01 June 2026 – 31 May 2030) |
| COORDINATING ORGANIZATION: | Sclavo Vaccines Association (SVA), Italy |
| PARTNERS: | 10 from 9 Countries |
| CONTACT: | denstar@sclavo.org |
The DENSTAR project aims to generate data required for the licensure of DengiAllTM, a tetravalent live attenuated dengue vaccine, in sub-Saharan Africa (sSA) and to facilitate its broader use globally. The project aligns with the Global Health EDCTP3 programme to tackle Neglected Tropical Diseases (NTDs), including Dengue fever, and to reduce the disease burden in Africa, in support of the Sustainable Development Goals and improved health outcomes for vulnerable communities.
Dengue is a mosquito borne viral disease, transmitted to humans by the bite of infected mosquitoes (Aedes aegypti and Aedes albopictus). Most cases are asymptomatic or cause mild febrile illness, but severe dengue may involve shock, severe bleeding or severe organ impairment, posing a significant risk to life. With no specific antiviral treatment available, prevention relies mainly on mosquito control, which is increasingly challenged by insecticide resistance, climate change, rapid urbanization, and limited community engagement. Existing dengue vaccines provide only partial and context-specific protection, with safety and eligibility restrictions that limit their broad use. A safe, effective dengue vaccine, suitable across age groups, regardless of serostatus, and providing long lasting immunity is much needed to complement vector controls and reduce the disease burden in sSA.
DengiAllTM is a tetravalent live attenuated dengue vaccine in late stage of development and is ready for licensure for use in adults in India. Pilot data indicate that DengiAllTM is safe and induces balanced and robust immune response against all 4 serotypes[1], while efficacy results from a Phase III study are expected in 2026. The vaccine is particularly suitable for use in the lower- and middle-income countries as it is a single-dose vaccine, with cost-efficient manufacturing suitable for tech-transfer and ideal for mass deployment in public health setting and vaccination campaigns. In addition, unlike other dengue vaccines, which require prior serological testing (a major challenge in developing regions), this vaccine can be safely administered to everyone, regardless of exposure status.
DENSTAR’s Objectives
By combining vaccine development, clinical research, and capacity strengthening, DENSTAR seeks to advance equitable access to dengue prevention and reduce the growing burden of dengue in Africa.
DENSTAR Workplan
The DENSTAR project is structured around seven interlinked Work Packages (WPs):
PARTNERS
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Sclavo Vaccines Association – SVA – Italy |
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Johns Hopkins University (JHU) – United States |
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Centre de Recherches Medicales de Lambaréné (CERMEL) – Gabon |
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Instituto Nacional de Saúde (INS) – Mozambique |
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Kwame Nkrumah University of Science and Technology (KNUST) – Ghana |
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Universitätsklinikum Heidelberg (UKHD) – Germany |
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International Vaccine Institute (IVI) – South Korea |
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Institut National De Recherche Biomedicale Du Zaire (INRB) – Democratic Republic of the Congo |
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National Institute of Allergy and Infectious Diseases (NIAID) – United States |
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Panacea Biotec Limited (PBL) – India |
Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or Global Health EDCTP3 JU. Neither the European Union nor the granting authority can be held responsible for them.