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First patient receives dengue vaccine in phase 3 trial
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Takeda Pharmaceutical has initiated its phase 3 Tetravalent Immunization against Dengue Efficacy Study and vaccinated its first patient with TAK-003, a live-attenuated tetravalent dengue vaccine candidate, according to a press release.
In the TIDES trial, approximately 20,000 healthy children aged 4 to 16 years living in dengue-endemic countries in Latin America and Asia will be dosed with TAK-003 — a vaccine based on a live-attenuated dengue serotype 2 virus. The double blind, randomized and placebo-controlled trial will evaluate the efficacy of the vaccine in protecting patients against symptomatic dengue fever caused by any of the four virus serotypes, regardless of age and whether the individual has previously been exposed to the virus, the release said. In addition, the study will evaluate safety and immunogenicity of the vaccine, and it will include patients receiving two doses of the vaccine or placebo 90 days apart.
“This is a significant achievement for Takeda’s vaccine program and underscores our ongoing commitment to addressing critical global health threats,” Rajeev Venkayya, MD, president of Takeda’s global vaccine business unit, said in the release. “The progress of our dengue program, along with other recent achievements, such as phase 2b field trial initiation for our norovirus vaccine candidate and our partnership with the Bill & Melinda Gates Foundation to develop a Sabin-strain inactivated poliovirus vaccine (sIPV) exemplify how we are researching, developing and providing vaccines to protect populations in need, wherever they may reside.”
According to the release, in phase 1 and 2 studies, TAK-003 induced neutralizing antibody responses against all four dengue virus serotypes across various age groups and in both seropositive and negative individuals with no observed safety concerns.
Interim results of a separate phase 2 study (DEN-203) showed the candidate to be generally safe and well-tolerated, and adults vaccinated with two doses had a sustained immune response against all four serotypes of the dengue virus at 2 years, according to the release. Interim results of the phase 2 DEN-204 trial also showed an acceptable safety profile in endemic pediatric populations, as well as antibody responses against the four dengue serotypes in dengue seropositive and seronegative participants, with a sustained immune response through 6 months.
“The initiation of phase 3 trials for our dengue vaccine candidate is a critical milestone, bringing us closer to delivering a vaccine that can address important unmet needs in dengue prevention,” Venkayya said.
Disclosure: Venkayya is employed by Takeda Pharmaceutical.