Takeda said Tuesday that a Phase III study of its live-attenuated tetravalent dengue vaccine candidate TAK-003 achieved its primary efficacy endpoint, with the immunisation effective at preventing dengue fever caused by any of the four serotypes of the virus. Rajeev Venkayya, president of the company's global vaccine business unit, noted "we are advancing the clinical development, commercial manufacturing and stakeholder consultations to support a potential future global launch of the vaccine."
The ongoing TIDES trial 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. Participants were randomly assigned to receive either TAK-003 or placebo by subcutaneous injection on day one and day 90.
The current analysis comes from the first part of the trial, which evaluated vaccine efficacy and safety through 15 months after the first dose. The second part of the study will continue for a further six months to complete the assessment of the secondary endpoints of vaccine efficacy by serotype, baseline serostatus and severity. The final portion of the trial will evaluate vaccine efficacy and long-term safety by following participants for an additional three years.
TAK-003 was found to be "well tolerated with no significant safety concerns identified in analyses to date," Takeda said. The company added that the first two parts of the study will be used to support regulatory submissions of the vaccine candidate. Venkayya declined to speculate regarding the potential duration of follow-up required by regulators, but cautioned "I do think it's going to be more than one year."
In 2017, Sanofi restricted use of its dengue vaccine Dengvaxia to patients previously exposed to the virus following an analysis indicating significant differences in vaccine performance according to prior dengue infection. Officials in the Philippines later halted the country's dengue immunisation programme. Sanofi has denied that any deaths related to the vaccine had occurred in the Philippines, although officials there later claimed some Filipino children who died after receiving Dengvaxia had exhibited signs of "severe dengue."
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