Vital dengue vaccine offers over four years’ protection following successful clinical trial

Takeda has announced that its dengue vaccine, TAK-003, prevented 84% of hospitalised cases and 61% of symptomatic cases. Furthermore, there were no important safety risks identified among the overall population throughout the four and a half years following vaccination during the phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial.

TIDES is a double-blind, randomised, placebo-controlled trial is evaluating the safety and efficacy of two TAK-003 doses. It involves the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents.

The new long-term results back-up previously published TIDES data which demonstrated the candidate vaccine met its primary endpoint of overall 80.2% efficacy at the 12-month follow-up, as well as all secondary endpoints for which there were a sufficient number of dengue cases at 18-months follow-up, including 90.4% hospitalised dengue.

“The burden of dengue is far reaching, and over half of the world’s population is at risk of dengue each year,” said Eng Eong Ooi from the Duke-NUS Medical School. “There is an urgent need for impactful prevention tools to combat the disease. The long-term TIDES results indicate that TAK-003 could be an important addition to the limited tools we have to prevent dengue, particularly given the demonstrated protection against hospitalisations.”

“Dengue is a complex, global disease, and the TIDES trial was designed to account for this, including both dengue-naïve and dengue-exposed populations in Latin America and Asia where outbreaks are prevalent, with evaluation over four and a half years,” added Gary Dubin, president, global vaccine business unit at Takeda. “We are proud that the results continue to demonstrate the efficacy and safety of TAK-003 and its ability to provide long-term protection against dengue.”

While the long-term follow-up for the primary two-dose series has been completed, the TIDES trial continues to evaluate the safety and efficacy of a booster dose. TIDES trial is Takeda’s largest interventional clinical trial to date – enrolling more than 20,000 healthy children and adolescents of four to 16 years of age, across eight dengue-endemic countries.