Objective
The DENSTAR project aims to make a live attenuated tetravalent Dengue vaccine available in Africa and generate data supporting its broader use. DENSTAR aligns with the call’s objective accelerating the development of a safe and effective Dengue vaccine against Dengue in Sub-Saharan Africa (sSA). Panacea Biotec, an Indian vaccine manufacturer, is developing a live attenuated tetravalent Dengue vaccine “DengiAll”, based on the US NIH-NIAID technology (TV003). Preclinical toxicology and Phase I/II studies were completed, and DengiAll is currently undergoing phase III study in adults in India with results expected in 2026. NIH and other research groups have performed multiple clinical studies on NIH Dengue vaccine, indicating that the vaccine is safe and efficacious with demonstrated efficacy against Dengue serotype 1, 2 and 3. No serious safety concern, such as severe dengue due to antibody dependent enhancement (ADE), was reported for TV003 in a field efficacy study in Brazil. We intend to conduct a multi-center population-bridging trial in sSA including Ghana, Mozambique and Republic Democratic of Congo, to evaluate DengiAll safety and immunogenicity, and compare results with phase III study data from India. We plan to evaluate the efficacy of DengiAll against Dengue virus serotype 4 (DEN4) using controlled human infection model (CHIM). Although efficacy data for the NIH Dengue vaccine against other serotypes is available, there is no evidence for any live attenuated vaccine against DEN4 in humans. This gap has implications for safety and acceptability. To address this, we will establish a DEN4 human challenge model and conduct a DEN4 CHIM study in Gabon to evaluate DengiAll's efficacy. Upon successful completion of the population-bridging study and the efficacy trial in India, the data will be used to seek marketing authorization in sSA. A safe, effective, and affordable vaccine will be crucial in addressing the rising Dengue burden in sSA.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences health sciences infectious diseases viral diseases RNA viruses
- natural sciences biological sciences microbiology virology
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs vaccines
- medical and health sciences basic medicine toxicology
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-JU-GH-EDCTP3-2025-01-two-stage
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
53100 Siena
Italy
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.