Takeda Pharmaceutical has reported that its tetravalent vaccine candidate, TAK-003, offered protection against dengue illness and hospitalisation in the ongoing Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial.
Dengue is a mosquito-borne viral disease that spreads through Aedes aegypti mosquitoes.
The double-blind, randomised, placebo-controlled trial is assessing the safety and efficacy of two doses of TAK-003, which is based on a live-attenuated dengue serotype 2 virus.
TIDES will determine the vaccine’s ability to prevent symptomatic dengue fever of any severity and caused by any of the four dengue virus serotypes.
It involves more than 20,000 healthy children and adolescents aged four to 16 at sites in Latin American and Asian countries where dengue is prevalent.
Trial subjects were given either a subcutaneous dose of 0.5ml TAK-003 or placebo on days one and 90.
According to the safety and efficacy data from the three-year follow-up exploratory analysis, TAK-003 showed 62% overall vaccine efficacy (VE) against virologically confirmed dengue with a VE of 65% and 54.3% in seropositive and seronegative individuals, respectively.
The vaccine candidate had a VE of 83.6% against hospitalised dengue.
Takeda noted that the varied VE by serotype was in line with previously reported results.
TAK-003 was found to be well-tolerated, with no significant safety risks or disease progression observed.
Takeda Pharmaceutical Dengue global programme leader Derek Wallace said: “Our dengue vaccine candidate continued to provide protection against dengue throughout three years and was especially robust in preventing hospitalisation.
“These results reinforce my confidence that TAK-003 can help address the significant global burden of dengue.”
The company earlier reported that the TIDES trial met its primary endpoint of overall VE against dengue at 12-months follow-up and all secondary endpoints.
Takeda included the 36-month TIDES data in its regulatory filings seeking approval for TAK-003 in various countries, as well as the EU, to prevent dengue in people aged four to 60. The company will seek US approval later this year.