Takeda Pharmaceutical has reported positive results from the ongoing Phase III TIDES clinical trial of its dengue vaccine candidate, TAK-003.
TAK-003 is a tetravalent vaccine candidate based on a live-attenuated dengue serotype 2 virus, which is said to offer the genetic ‘backbone’ for all four vaccine viruses.
Data from the primary endpoint analysis of TIDES showed that Takeda’s vaccine offered protection against virologically-confirmed dengue (VCD), which is the trial’s primary goal.
The trial involved over 20,000 children aged four to 16 years in Latin America and Asia. Participants were administered with two doses of TAK-003 or placebo on day one and day 90.
A 12-month follow-up after the second dose demonstrated vaccine efficacy (VE) of 80.2%.
Exploratory analyses of secondary endpoints revealed an 82.2% vaccine efficacy in participants who were seropositive at baseline and 74.9% among baseline seronegatives.
Takeda said that the vaccine candidate had similar degrees of protection in people who had and had not been previously infected with dengue virus.
However, the company noted inconclusive data that indicated a lack of efficacy for dengue serotype 3 in seronegatives, while the efficacy was 71.3% in seropositives.
A 95.4% decrease in dengue-associated hospitalisations was found with further exploratory analyses.
Data also showed that TAK-003 was generally well-tolerated without any important safety risks. The safety profile was consistent with that observed in prior studies.
Takeda Pharmaceutical Global Vaccine business unit president Rajeev Venkayya said: “While more data is needed to fully understand the safety and efficacy profile of TAK-003, these findings strongly suggest that it could help address the massive global burden of dengue in all populations.
“We look forward to sharing more data in the coming weeks, and engaging health authorities and the scientific, public health and medical communities on these findings, priorities for future evidence generation, and ways we can work together to maximise the reach and impact of this vaccine upon licensure.”
The TIDES trial will be continued for a total of four-and-a-half years to determine the safety and efficacy of Takeda’s dengue vaccine candidate.
Separately, the company opened a new €130m plant in Singen, Germany, to manufacture TAK-003.