Takeda reports positive results from interim analysis of mid-stage study for dengue vaccine

Takeda announced that an interim analysis of a Phase II study published in The Lancet Infectious Diseases showed that its vaccine candidate TAK-003 was associated with a reduction in the incidence of dengue in children and adolescents. Results from the DEN-204 trial were also presented at the American Society of Tropical Medicine and Hygiene (ASTMH) annual meeting.

The ongoing study is evaluating the safety and immunogenicity of TAK-003 in 1794 children and adolescents ages 2 through 17 living in dengue-endemic areas. The trial's main objective is to assess the vaccine-induced antibody levels to all four types of dengue virus following different vaccine schedules. Subjects in the study received either one primary dose of TAK-003, two primary doses of TAK-003 administered three months apart, one primary dose of TAK-003 followed by a booster dose one year later, or placebo.

Results showed that symptomatic, virologically confirmed dengue was recorded in 21, or 1.3 percent, of the 1596 participants who received TAK-003, compared with nine, or 4.5 percent, of the 198 placebo recipients. Takeda noted that the immune response against all four dengue serotypes was durable across all vaccinated groups, with antibody levels persisting out to 18 months regardless of vaccine schedule.

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The company said that the findings support the use of a two-dose regimen, administered three months apart for the ongoing global pivotal Phase III trial dubbed TIDES. Data from the study, which completed enrolment in April, will be available in late 2018. The tetravalent vaccine is based on a live, attenuated dengue serotype 2 virus, with Takeda unveiling plans last year to invest more than 100 million euros ($116 million) to build a new manufacturing facility for TAK-003 in Germany.

In 2015, Sanofi's Pasteur division received approval from regulators in Mexico to launch Dengvaxia in the country, making it the first vaccine to be licensed in the world for the prevention of dengue. Although Phase III study data showed that Dengvaxia cut the number of symptomatic virologically-confirmed cases of dengue from any serotype by 56.5 percent, the vaccine offered less protection for young children and was less effective against dengue serotype 2, offering only 35-percent protection.

Sanofi previously said that Dengvaxia could generate annual sales of more than $1 billion, although the vaccine only recorded revenue of 55 million euros ($64 million) last year. Meanwhile, analysts estimate that Dengvaxia will post annual sales of around 360 million euros ($416 million) by 2022.

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