Takeda announced promising preliminary results from the Phase 3 TIDES trial evaluating TAK-003, an investigational tetravalent dengue vaccine.
TAK-003 is based on a live-attenuated dengue serotype 2 virus. The TIDES trial is investigating the safety and efficacy of 2 doses of TAK-003 in preventing dengue fever caused by any of the 4 dengue virus serotypes. The double-blind, randomized, placebo-controlled study includes over 20,000 healthy children and adolescents aged 4 to 16 living in dengue-endemic areas. Study participants were randomly assigned to receive either TAK-003 0.5mL or placebo, via subcutaneous injection on Day 1 and 90.
Preliminary data through 15 months (Part 1 of the trial) showed that the vaccine met the primary efficacy endpoint of preventing virologically-confirmed dengue fever induced by any dengue serotype. In addition, the vaccine was found to be well-tolerated with no significant safety concerns.
“We are excited to publish the data in a peer-reviewed journal as quickly as possible,” said Rajeev Venkayya, MD, and President at Takeda. Part 2 of the trial will evaluate secondary outcome measures including vaccine efficacy by serotype, baseline serostatus and severity; long-term safety and efficacy evaluation (an additional 3 years) will be included in the third part of the study.
Takeda expects to file for licensure once Part 2 of the study is complete.
For more information visit Takeda.com