Japanese drugmaker Takeda Pharmaceutical Company has said that its dengue vaccine candidate has demonstrated protection against virologically-confirmed dengue (VCD) in children between 4 to 16 years.
The trial of Takeda’s dengue vaccine candidate (TAK-003) was published in the New England Journal of Medicine, a statement from the company said.
The virus infections caused by all four serotypes were observed in the global TIDES trial. The trial will continue to assess safety and efficacy in the research subjects for a total of four and a half years.
Rajeev Venkayya, Takeda President with the Global Vaccine Business Unit, stated, “We are excited to share this long-anticipated data from our TIDES trial, which is evaluating the performance of our dengue vaccine candidate in a diverse set of countries across Asia and Latin America, and in a study population that intentionally includes a large proportion of children who had never been exposed to dengue.”
He said, “While more data is needed to fully understand the safety and efficacy profile of the new dengue vaccine, these findings strongly suggest that it could help address the massive global burden of dengue in all populations.”
The efficacy of the vaccine was at 80.2 percent in the 12-month period after the second dose, which was administered three months after the first dose.
Similar degrees of protection were seen in individuals who had and had not been previously infected with dengue, based on planned exploratory analyses of secondary endpoints, the company said.
“Historically, new vaccine development against dengue has been challenging, especially for people who haven’t previously been exposed to the disease, and these results demonstrate protection from dengue fever, including among many participants without prior dengue,” he added.