Japan's Dengue Vaccine Candidate Demonstrated Long-Term Safety and Efficacy

Japan-based 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.

Furthermore, Takeda stated in a press statement issued on May 22, 2021, 'no important safety risks were identified through three years after vaccination in the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial in Latin America and Asia.'

Takeda's TAK-003 is a live-attenuated tetravalent dengue vaccine candidate, preventing dengue fever caused by any of the four serotypes of the dengue virus that causes dengue. TAK-003 (TDV) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all 4 dengue serotypes.

“Dengue epidemics occur suddenly, and hospitals can become overwhelmed with severe disease cases and people seeking testing,” commented 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.

The safety and efficacy results from the 36-month follow-up exploratory analysis of TIDES found 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.

This study's results reinforce the potential of TAK-003 to help protect those living in or traveling to dengue-endemic countries.

“Our dengue vaccine candidate continued to protect against dengue throughout three years and was especially robust in preventing hospitalization,” added Derek Wallace, VP, Dengue Global Program Leader at Takeda.

Dengue viruses are spread to people through the bite of an infected Aedes species (Ae. aegypti or Ae. albopictus) mosquito. Dengue is common in more than 100 countries around the world, says the U.S. CDC.

The CDC recently issued Travel Alert regarding Dengue outbreaks in the Americas, Asia, and the Pacific Islands.

Takeda Pharmaceutical is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people, and the planet. For more information, visit www.TakedaVaccines.com.