Takeda Pharmaceutical Company Limited today announced that the pivotal Phase 3 trial of its dengue vaccine candidate met the primary efficacy endpoint.

Takeda’s Dengue Vaccine Candidate Meets Primary Endpoint in Pivotal Phase 3 Efficacy Trial (Photo: David Parnes Photography)
Takeda’s Dengue Vaccine Candidate Meets Primary Endpoint in Pivotal Phase 3 Efficacy Trial (Photo: David Parnes Photography)

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.

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.

The TIDES trial is continuing and additional results are expected later this year, along with results from other Phase 3 studies.

“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.

TAK-003 is not currently licensed anywhere in the world.