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Strong Phase 3 showing for Takeda's dengue vaccine, but concerns remain over consistent coverage

Published on 07/11/19 at 09:27am

Takeda has unveiled new data from its ongoing Phase 3 trial investigating the efficacy of its vaccine candidate TAK-003 in the prevention of the mosquito-borne virus dengue, confirming its ability to convey protection against virologically-confirmed cases in paediatric patients from four to 16 years old.

In the 12-month period following the second dose of the vaccine, which was administered three months after the first dose, Takeda’s product was found to be 80.2% effective. This considerably outclasses the 59.2% efficacy displayed by Sanofi’s rival Dengvaxia candidate within the first year. The vaccine was also shown to demonstrate a 95.4% reduction in dengue-associated hospitalisations.

“According to the World Health Organization, dengue represents one of the ten biggest global health threats, and it is critical that we have access to a safe and effective vaccine candidate that can reduce the devastating impact dengue fever has in endemic regions,” remarked Dr In-Kyu Yoon, Senior Advisor at the International Vaccine Institute. “Historically, vaccine development against dengue has been challenging, especially for people who haven’t previously been exposed to dengue, and these results demonstrate protection from dengue fever, including among many participants without prior dengue.”

In patients who had never previously contracted the virus, vaccine efficacy was recorded at 74.9% in all four virus serotypes, according to planned exploratory analyses of secondary endpoints; however, this was significantly lower than the 97.7% efficacy recorded in dengue 2, leading to concerns over inconsistent protection across all four serotypes in all patient populations.  

Dr Stephen Thomas of the State University of New York Upstate Medical University, called the results “disappointing from the perspective that the field desires a vaccine with protective efficacy.”

Takeda also confirmed that the vaccine’s efficacy against severe forms of the disease could not be assessed due to a limited number of should cases available for study. The ongoing trial is due to continue for another four and a half years, with full details to be presented at an upcoming medical conference.

Matt Fellows

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