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news.Takeda Pharmaceutical’s investigational live-attenuated tetravalent dengue vaccine (TAK-003) candidate has met the primary endpoint in the pivotal phase 3 efficacy trial.
Image: Takeda’s dengue vaccine candidate meets primary endpoint in pivotal phase 3 efficacy trial. Photo: courtesy of David Parnes Photography.
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The first analysis of the tetravalent immunization against dengue efficacy study (TIDES) trial demonstrated that TAK-003 effectively prevented dengue fever caused by any of the four serotypes of the virus.
According to the company, The TIDES trial is continuing and additional results are expected at the end of this year along with results from other phase 3 studies.
Takeda has enrolled more than 20,000 healthy children and adolescents aged between four and 16 years living in dengue-endemic areas in the double-blind, randomized and placebo-controlled phase 3 TIDES study.
The company has designed the study to assess the efficacy, safety and immunogenicity of two doses of TAK-003 in both dengue exposed and naïve individuals. The TAK-003 is not yet approved anywhere in the world.
Participants in the study have been randomly assigned to secure either TAK-003 0.5 mL or placebo by subcutaneous injection on day 1 and day 90.
The study is divided into three parts, including current analysis with evaluated vaccine efficacy (VE) and safety through 15 months after the first dose.
Second part continues for an additional six months to complete the assessment of the secondary endpoints of VE by serotype, baseline serostatus and severity, while part three assesses VE and long-term safety by following participants for an additional three years.
The trial is conducting at sites in dengue-endemic areas in Latin American countries such as Brazil, Colombia, Panama, Dominican Republic and Nicaragua, and Asian countries such as Philippines, Thailand and Sri Lanka.
Takeda global vaccines business unit Dr Rajeev Venkayya said: “We are very encouraged by the performance of our dengue vaccine candidate in the study. This brings us one step closer to helping the world tackle the massive burden of dengue.
“We are excited to publish the data in a peer-reviewed journal as quickly as possible. In parallel, we are advancing the clinical development, commercial manufacturing, and stakeholder consultations to support a potential future global launch of the vaccine.”
