− Takeda’s Dengue Vaccine Candidate (TAK-003) Prevented 83.6% of Hospitalizations and 62.0% of Dengue Illness Overall, With No Identified Important Safety Risks Through Three Years Following Vaccination in Ongoing Pivotal Phase 3 TIDES Trial
− Regulatory Filings for TAK-003 Progressing in European Union and in Many Dengue-Endemic Countries; Filing in United States Planned for Later This Year
− Dengue is the Fastest-Spreading Mosquito-Borne Viral Disease With an Estimated 390 million cases and 500,000 Hospitalizations per Year Globally, With Limited Options for Prevention
Takeda Pharmaceutical Company Limited announced that its dengue vaccine candidate (TAK-003) demonstrated continued protection against dengue illness and hospitalization, regardless of an individual’s previous dengue exposure, with no important safety risks identified through three years after vaccination in the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. TIDES enrolled more than 20,000 healthy children and adolescents ages four to 16 years in dengue-endemic countries in Latin America and Asia.
“Dengue epidemics occur suddenly, and hospitals can become overwhelmed with severe disease cases and people seeking testing,” said LakKumar Fernandoi, M.D., Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Sri Lanka and a primary investigator of the TIDES trial. “Results from the long-term analysis of Takeda’s dengue vaccine candidate suggest that it could help with outbreak prevention, reduce rates of hospitalization and protect people from dengue regardless of their previous exposure. Importantly, no important safety risks were identified.”
Safety and efficacy results from the 36-month follow-up exploratory analysis of TIDES were presented on May 22, 2021, at the 17th Conference of the International Society of Travel Medicine (CISTM). Through three years (36 months after the second dose), TAK-003 demonstrated overall vaccine efficacy (VE) of 62.0% (95% CI: 56.6% to 66.7%) against virologically-confirmed dengue (VCD), with 65.0% VE (95% CI: 58.9% to 70.1%) in seropositive individuals and 54.3% VE (95% CI: 41.9% to 64.1%) in seronegative individuals. TAK-003 also demonstrated 83.6% VE (95% CI: 76.8% to 88.4%) against hospitalized dengue, with 86.0% VE (95% CI: 78.4% to 91.0%) in seropositive individuals and 77.1% VE (95% CI: 58.6% to 87.3%) in seronegative individuals. Observations of varied VE by serotype remained consistent with previously reported results. No evidence of disease enhancement was observed. TAK-003 was generally well tolerated, and there were no important safety risks observed. The results reinforce the potential of TAK-003 to help protect those who are living in or traveling to dengue-endemic countries.
“Our dengue vaccine candidate continued to provide protection against dengue throughout three years, and was especially robust in preventing hospitalization,” said Derek Wallace, VP, Dengue Global Program Leader at Takeda. “These results reinforce my confidence that TAK-003 can help address the significant global burden of dengue.”
As previously reported, the TIDES trial met its primary endpoint of overall VE against VCD at 12-months follow-up (VE: 80.2%; 95% CI: 73.3% to 85.3%; p<0.001) and all secondary endpoints for which there were a sufficient number of dengue cases (measured at 18-months follow-up). The TIDES trial has been amended to include the evaluation of a booster dose to address the waning of overall VE observed over time (from 12 through 36 months after the second dose), largely driven by outpatient dengue. Takeda intends to publish results of the 36-month exploratory analysis in a peer-reviewed journal this year.
TIDES safety and efficacy data through 36-months follow-up was included in regulatory submissions to the European Union and dengue-endemic countries and will be part of additional filings planned for 2021, including in the United States. Takeda will seek an indication for TAK-003 for the prevention of dengue disease in individuals four to 60 years of age, regardless of previous virus exposure, based on data in both adults and children. There remains a need for dengue vaccines that can be used in both dengue-naïve and dengue-exposed adults and children.