A major international effort has been launched to accelerate the licensure and global rollout of a new dengue vaccine, with a strong focus on sub-Saharan Africa, where infections are rising but remain significantly under-detected.

 

Starting 1 June, the four-year DENSTAR project will work to advance the regulatory approval of DengiA/1, a tetravalent live-attenuated dengue vaccine, and expand its global access. 

 

Funded under the Global Health European & Developing Countries Clinical Trials Partnership 3 Joint Undertaking (GH EDCTP3 JU) with support from the European Union, the initiative aligns with efforts to tackle Neglected Tropical Diseases, including dengue fever.

 

Dengue, a mosquito-borne viral disease, is emerging as a growing public health threat across Africa. While many infections are mild, severe cases can rapidly escalate to shock, internal bleeding, and organ failure. 

 

With no specific antiviral treatment available, prevention depends largely on mosquito control measures—strategies increasingly undermined by climate change, rapid urbanisation, and insecticide resistance.

 

Existing vaccines provide only partial protection and are difficult to deploy at scale, intensifying demand for a safer, more effective, and widely accessible solution.

 

The DENSTAR consortium is coordinated by the “Sclavo Vaccines Association”, a non-profit organisation based in Siena, Italy, dedicated to supporting vaccine research and development in low- and middle-income countries. 

 

The project brings together 10 partners from nine countries across Europe, Africa, the United States, India, and South Korea, including universities, research institutes, a biotech company, and public health organisations.

 

A central role is played by Panacea Biotec Limited, developer of DengiA/1, a tetravalent vaccine designed to protect against all four dengue virus serotypes and currently in late-stage development in India. The collaboration is positioned as a public–private partnership aimed at improving equitable access to dengue prevention tools.

 

The project will conduct Phase 1/3 clinical studies in healthy African adults and children to evaluate the vaccine’s safety and efficacy in local populations, paving the way for potential regulatory approval and deployment in sub-Saharan Africa.

 

It will also address key scientific gaps through Controlled Human Infection Model (CHIM) studies, including evaluation of efficacy against dengue virus serotype 4 (DENV-4)—an area where no vaccine has yet demonstrated clear protection.

 

DengiA/1 is designed for large-scale use in lower- and middle-income countries, offering several practical advantages: it is single-dose, cost-efficient to manufacture, and does not require prior serological testing, simplifying deployment in diverse populations.

 

Donata Medaglini, Deputy Rector of the University of Siena and Chief Scientific Officer of SVA, said: "DENSTAR is a unique consortium that concentrates international excellence in vaccine research, development, manufacture, and clinical trials. 

 

"By uniting top experts from academia, industry, and non-profit organization we are forging a true public-private partnership to bridge critical gaps in dengue prevention. By making a dengue vaccine available in Africa, we will uphold the universal right of every individual to a healthy and productive life. We have high hopes to advance the licensure of DengiAII in sub-Saharan Africa and beyond."

 

Ellis Owusu-Dabo, Scientific Project Lead of DENSTAR, noted: "Dengue infections can range from mild to potentially fatal in the most severe cases. It is becoming more common in sub-Saharan African, driven primarily by climate change. 

 

"The primary challenge of the DE NSTAR project is to advance a live-attenuated tetravalent dengue vaccine through immunobridging and controlled human infection model studies to enable its licensure in sub-Saharan Africa, where dengue infections have become more common."

 

Khalid Ali Syed of Panacea Biotec Limited added: "The project efforts are expected to have a lasting impact on global health, extending beyond the project's immediate scope and duration by reducing the dengue burden, improving quality of life, alleviating pressure on health systems, and upholding the universal right to a healthy, productive life."

 

Till Bärnighausen and Florian Marks highlighted the project’s capacity-building focus, stating: "A key strength of DENSTAR is its commitment to sustainable capacity advancement alongside vaccine development. 

 

"The project plans to support training opportunities for MPH and PhD students embedded in the participating institutions, while also strengthening the readiness of African study sites to conduct high-quality clinical trials and related project activities. By working jointly with participating sites and institutions, DENSTAR will help build locally led research capacity that continues beyond the lifetime of the project."