Cambridge and Osaka – Takeda Pharmaceutical Company Limited today announced that the pivotal Phase 3 trial of its dengue vaccine candidate met the primary efficacy endpoint.
This first analysis of the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial showed that the company’s investigational live-attenuated tetravalent dengue vaccine (TAK-003) was efficacious in preventing dengue fever caused by any of the four serotypes of the virus. While review of the extensive data set is ongoing, TAK-003 was well tolerated with no significant safety concerns to date. The TIDES trial is continuing and additional results are expected later this year, along with results from other Phase 3 studies.1
“We are very encouraged by the performance of our dengue vaccine candidate in the study. This brings us 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.”
The TIDES trial, Takeda’s largest interventional clinical trial to date, enrolled over 20,000 healthy children and adolescents ages four to 16 years living in dengue-endemic areas. The study was designed to evaluate the efficacy, safety and immunogenicity of two doses of TAK-003, in both dengue exposed and naïve individuals.1
TAK-003 is not currently licensed anywhere in the world. In addition to dengue, Takeda is developing vaccines to address other high-priority infectious diseases, including Zika, norovirus and polio.
About the Phase 3 TIDES (DEN-301) Trial
The double-blind, randomized and placebo-controlled Phase 3 TIDES trial is evaluating the safety and efficacy of two doses of TAK-003 in 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.1 Study participants were randomly assigned to receive either TAK-003, 0.5 mL or placebo, by subcutaneous injection on Day 1 and Day 90.1 The study is comprised of three parts. The current analysis, Part 1, evaluated vaccine efficacy (VE) 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 VE by serotype, baseline serostatus and severity. Part 3 evaluates VE and long-term safety by following participants for an additional three years.1 The Part 1 and Part 2 data will form the basis for filing for licensure.
The trial is taking place at sites in dengue-endemic areas in Latin America (Brazil, Colombia, Panama, Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka) where there are unmet needs in dengue prevention and where severe dengue is a leading cause of serious illness and death among children.1 Baseline blood samples were collected from all individuals participating in the trial to allow for evaluation of safety and efficacy based on serostatus. Takeda and an independent Data Monitoring Committee of experts are actively monitoring safety on an ongoing basis.