Takeda completes enrolment in late-stage study of experimental dengue vaccine TAK-003

Takeda on Wednesday announced that it completed the enrolment of 20 100 children and adolescents into a Phase III study of its investigational live-attenuated tetravalent dengue vaccine candidate TAK-003. The company noted that the TIDES trial, which was initiated in September 2016, will be the largest vaccine clinical study it has conducted, with initial results expected next year.

In December 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.

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Takeda explained that the TIDES study will assess the efficacy, safety and immunogenicity of two doses of TAK-003 administered three months apart versus placebo. The drugmaker added that efficacy will be assessed after the accrual of 120 cases of virologically-confirmed dengue and after at least 12 months following the administration of the second dose.

The primary endpoint of the study is vaccine protection against virologically-confirmed dengue of any severity caused by any of the four dengue virus serotypes irrespective of previous exposure to the virus. Meanwhile, secondary goals include vaccine efficacy in preventing dengue, hospitalisation and severe dengue by any serotype, as well as the frequency and severity of adverse or serious adverse events.

Takeda noted that the study will be conducted in eight dengue-endemic countries in Latin America and Asia, namely Brazil, Colombia, Panama, Dominican Republic, Nicaragua, Philippines, Thailand and Sri Lanka. Rajeev Venkayya, president of the company's global vaccine business unit, stated "the successful enrolment of more than 20 000 children and adolescents...reflects Takeda's prioritisation of dengue and the substantial capabilities of our global organisation." Last year, the drugmaker unveiled plans to invest more than 100 million euros ($107 million) to build a new manufacturing facility for TAK-003 in Germany.

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