Takeda Pharmaceutical Company has reported positive results from the ongoing Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of its dengue vaccine after the trial met its primary efficacy endpoint.
Results demonstrated that the company’s dengue vaccine candidate TAK-003 was effective in preventing dengue fever caused by any of the four serotypes of the virus.
The vaccine candidate was also found to be well tolerated with no significant safety concerns so far.
Takeda is expected to provide additional data from the TIDES trial later this year.
Takeda Pharmaceutical Company global vaccine business unit president Rajeev Venkayya said: “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.
“In parallel, we are advancing the clinical development, commercial manufacturing, and stakeholder consultations to support a potential future global launch of the vaccine.”
TIDES is a Phase III, double-blind, randomised and placebo-controlled trial that enrolled more than 20,000 healthy children and adolescents aged four to 16 years living in dengue-endemic areas.
The trial investigated the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes.
Takeda randomly assigned the enrolled subjects to receive either 0.5ml TAK-003 or placebo by subcutaneous administration on days one and 90.
The trial consists of three parts, with Part I assessing the vaccine efficacy (VE) and safety 15 months after the first dose.
Part II was conducted for a further six months to complete the evaluation of the secondary endpoints of VE by serotype, baseline serostatus, and severity. Part III intends to analyse VE and long-term safety by following the subjects for an additional three years.
Takeda plans to use data from Part I and Part II to file for the licensure of TAK-003.
The trial is being conducted at sites in dengue-endemic areas in Latin America including Brazil, Colombia, Panama, Dominican Republic and Nicaragua, as well as in the Asian countries of the Philippines, Thailand and Sri Lanka.