Takeda's Dengue Vaccine Candidate TAK-003 Demonstrates Sustained Efficacy Over 4.5 Years in Pivotal Phase 3 Trial

Today, Takeda announced positive results from the pivotal Phase 3 clinical trial of its investigational dengue vaccine candidate, TAK-003. During the 54-month follow-up period after vaccination, TAK-003 demonstrated an efficacy of 84% in preventing dengue-related hospitalizations and 61% in preventing symptomatic dengue.

Dengue fever, a viral disease transmitted by mosquitoes, is one of the top 10 global health threats listed by the World Health Organization in 2019. Dengue fever is caused by various serotypes of the dengue virus. It is estimated that approximately 390 million people worldwide are infected each year, 500,000 are hospitalized, and 20,000 die as a result.

TAK-003 is a tetravalent vaccine based on the attenuated dengue virus (serotype 2). Trial results show that TAK-003 is 84.1% effective in preventing dengue fever hospitalizations, 85.9% effective in seropositive individuals, and 79.3% effective in seronegative individuals. In preventing symptomatic dengue fever, its efficacy is 64.2% in seropositive individuals and 53.5% in seronegative individuals.

In terms of safety, TAK-003 was well-tolerated with no significant safety risks identified. No evidence of disease enhancement was found in the 54-month follow-up analysis.

"Dengue imposes a profound disease burden, with half of the world's population at risk annually," said Dr. Eng Eong Ooi from Duke-NUS Medical School in Singapore. "There is an urgent need for effective prevention tools to combat this disease. The long-term study results indicate that TAK-003 could become an important tool in preventing dengue."

References:

[1] Takeda’s Dengue Vaccine Candidate Provides Continued Protection Against Dengue Fever Through 4.5 Years in Pivotal Clinical Trial. Retrieved June 9, 2022, from https://www.businesswire.com/news/home/20220609005106/en

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