A dengue vaccine candidate from a Japanese pharmaceutical has been found efficacious in preventing dengue fever caused by any of the four serotypes of the mosquito-borne virus in an ongoing trial.
Takeda Pharmaceutical Company Limited also reported that its TAK-003 vaccine was well tolerated with no significant safety concerns to date.
The trial is continuing and additional results are expected later this year, along with results from other Phase 3 studies, according to Takeda.
The encouraging performance of TAK-003 brings Takeda one step closer to helping the world tackle the massive burden of dengue, said Rajeev Venkayya, M.D., president of the Global Vaccine Business Unit at Takeda.
“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,” Venkayya added.
The trial involved more than 20,000 healthy children and adolescents ages four to 16 years living in dengue-endemic areas in Brazil, Colombia, Panama, Dominican Republic, Nicaragua, Philippines, Thailand and Sri Lanka. There are unmet needs in dengue prevention and severe dengue is a leading cause of serious illness and death among children in the said countries.
Study participants were randomly assigned to receive either TAK-003, 0.5 mL or placebo, by subcutaneous injection on Day 1 and Day 90.
The study is comprised of three parts. The current analysis, Part 1, evaluated vaccine efficacy and safety through 15 months after the first dose. Part 2 continues for an additional six months to complete the assessment of the secondary endpoints of efficacy by serotype, baseline serostatus and severity. Part 3 evaluates efficacy and long-term safety by following participants for an additional three years.
Dengue is the fastest spreading mosquito-borne viral disease and is one of the World Health Organization’s top ten threats to global health in 2019.