The first dengue vaccine candidate (CYD-TDV) to reach phase 3 clinical testing has shown moderate protection (56%) against the disease in Asian children, according to new research published in The Lancet.
Dengue is a mosquito-borne disease that infects around 390 million people each year, of whom about 96 million suffer from symptomatic infection. WHO estimates that the global burden of dengue has risen 30-fold over the past 50 years, with over half of the world’s population at risk of the disease.
There is no licensed vaccine available to treat or prevent dengue fever, and efforts to develop one have been complicated by the fact that dengue is caused by four distinct dengue viruses, and a vaccine must target all four serotypes (DENV 1–4).
This phase 3 trial took place in dengue-endemic areas across five countries in Asia, a region that accounts for over 70% of the global dengue burden. The study involved 10 275 healthy children aged 2 to 14 years who were randomly assigned to receive three injections of the CYD-TDV vaccine (6851) or a placebo (3424) at 0, 6, and 12 months, and followed for up to 2 years.
The researchers recorded 250 dengue cases more than 28 days after the third injection—117 in the vaccine group and 133 in the placebo group, demonstrating an overall protective efficacy of 56.5%.
The vaccine also showed 88.5% efficacy after 3 doses against severe disease (dengue haemorrhagic fever) which leads to hospitalisation for over half a million people (mostly children) every year, and 67% against dengue-associated hospitalisation.
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