First ever Phase III dengue fever vaccine trial complete

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According to Sanofi three-dose vaccine led to 56% reduction in cases of dengue fever


Geneva, 28 April 2014 - The GAVI Alliance welcomes the news of the completion of the first ever large-scale Phase III efficacy clinical trial for a dengue fever vaccine. This is an exciting development and one which GAVI will follow with continued interest.

Dengue fever is currently the second most prevalent vector-borne disease, posing a threat to nearly half the world’s population. Like malaria the disease is transmitted via mosquito bites. Each year there are as many as 100 million cases of dengue fever, with 500,000 cases of dengue haemorrhagic fever and an estimated 20,000 dengue-related deaths.

According to Sanofi, the study, conducted in Asia on more than 10,000 children aged between 2-14 years old, showed that the three-dose vaccine led to a 56% reduction of dengue disease cases. However, given that there are four disease-causing serotypes of the virus, it is not clear what subtype-specific protection this represents until full analysis is presented.

Although dengue vaccines were not shortlisted for GAVI Alliance support in the most recent Vaccine Investment Strategy (2013) these new results are an important step forward. GAVI will continue to monitor developments and looks forward to the publication of these encouraging results, and of the second complementary Phase III study by Sanofi involving more than 20,000 subjects in Latin America. The Alliance is especially interested in the subtype specific findings as well the vaccines ability to reduce severe, sometimes fatal cases of dengue fever.

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