TAK-003 is an investigational live-attenuated tetravalent dengue vaccine, preventing dengue fever caused by any of the four serotypes of the dengue virus.
January 29, 2019, Takeda announced TAK-003 which is in a pivotal Phase 3 trial met the primary efficacy endpoint.
Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses.
TAK-003 will be given as a single DV 0.5 mL subcutaneous injection on Day 1 and Day 90.
The double-blind, randomized and placebo-controlled Phase 3 TIDES trial evaluated the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity, due to any of the four dengue virus serotypes in children and adolescents.
TAK-003 was efficacious in preventing dengue fever caused by any of the four serotypes of the virus. While the review of the extensive data set is ongoing, TAK-003 was well tolerated with no significant safety concerns to date.
The TIDES trial, Takeda’s largest interventional clinical trial to date, enrolled over 21,000 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.
The Phase 3 clinical trial is continuing and additional results are expected later this year.
TAK-003 is not currently licensed anywhere in the world.
Clinical Trial NCT02747927: Efficacy, Safety, and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES)
- This Phase III, Double-Blind, Randomized, Placebo-Controlled Trial is to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in 21,000 Healthy Children Aged 4 - 16 Years Old
- The purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity, due to any of the four dengue virus serotypes in 4 to 16-year-old participants.