Takeda’s Dengue Vaccine Candidate Provides Continued Protection Against Dengue Fever Through 4.5 Years in Pivotal Clinical Trial

Takeda (TSE:4502/NYSE:TAK) today announced that its dengue vaccine candidate, TAK-003, prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases, with no important safety risks identified, in the overall population including both seropositive and seronegative individuals through four and a half years (54 months) after vaccination in the pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. These data were presented on June 9, 2022, at the 8^th Northern European Conference on Travel Medicine (NECTM8), with plans to feature the results at additional upcoming conferences.

“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, Ph.D., M.D., Duke-NUS Medical School, Singapore. “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 hospitalizations.”

Through four and a half years, TAK-003 demonstrated 84.1% vaccine efficacy (VE) (95% CI: 77.8, 88.6) against hospitalized dengue, with 85.9% VE (78.7, 90.7) in seropositive individuals and 79.3% VE (63.5, 88.2) in seronegative individuals. TAK-003 also demonstrated overall VE of 61.2% (95% CI: 56.0, 65.8) against virologically-confirmed dengue (VCD), with 64.2% VE (58.4, 69.2) in seropositive individuals and 53.5% VE (41.6, 62.9) in seronegative individuals. Observations of VE varied by serotype and remained consistent with previously reported results. TAK-003 was generally well tolerated, and there were no important safety risks identified. No evidence of disease enhancement was observed over the 54-month follow-up exploratory analysis.

“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,” said 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.”