Takeda’s Dengue Vaccine Candidate Demonstrates Protection in Children Ages Four to 16 Years, Regardless of Previous Dengue Exposure

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that results from the primary endpoint analysis of the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of its dengue vaccine candidate (TAK-003) were published in the New England Journal of Medicine. Takeda’s dengue vaccine candidate demonstrated protection against virologically-confirmed dengue (VCD), the trial primary endpoint, in children ages four to 16 years. Vaccine efficacy (VE) was 80.2% (95% confidence interval [CI]: 73.3% to 85.3%; p<0.001) in the 12-month period after the second dose, which was administered three months after the first dose. Similar degrees of protection were seen in individuals who had and had not been previously infected with dengue based on planned exploratory analyses of secondary endpoints (VE: 82.2% [95% CI: 74.5% to 87.6%] vs. VE: 74.9% [95% CI: 57.0% to 85.4%], respectively). Other exploratory analyses showed a 95.4% reduction in dengue-associated hospitalizations (95% CI: 88.4% to 98.2%). Efficacy against severe disease could not be assessed due to the limited number of cases. Onset of protection was seen after the first dose, with 81% VE (95% CI: 64.1% to 90.0%) between the first and second doses.

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Takeda's new dengue vaccine manufacturing plant in Singen, Germany. (Photo: Business Wire)

Takeda’s dengue vaccine candidate was generally well tolerated, and no important safety risks have been observed to date. The observed safety profile was consistent with results reported in previous studies of TAK-003.^1,2,3,4 The TIDES trial will continue to assess safety and efficacy in study subjects for a total of four and a half years.

“The results of this first analysis are very encouraging, indicating that the vaccine could potentially provide important public health benefits against dengue fever and hospitalization,” said Humberto Reynales, M.D., Ph.D., a lead author of the New England Journal of Medicine paper. “It will be important to further analyze the trial results over time in order to assess the long-term efficacy and safety of the vaccine. If longer follow-up data confirm this initial observation, we are looking at a significant step forward in the global fight against dengue.”