Takeda’s dengue vaccine candidate TAK-003 has been appeared to give protection against all four serotypes of the virus for no less than the year and a half. An 18-month interim analysis of an ongoing Phase 2 trial for the TAK-003 vaccine candidate has demonstrated promising outcomes in children and adolescents.
These discoveries were declared by Takeda Pharmaceutical Company Limited and published in The Lancet Infectious Diseases. Dengue fever is a mosquito-borne viral disease endemic in many tropical areas, infecting an estimated 390 million individuals and causing about 500,000 hospitalizations every year.
There is currently no treatment for dengue, and designing a vaccine against it has proven challenging because of the complexity of ensuring people against all four serotypes of the virus.
The Phase 2 DEN-204 trial was designed to assess the safety and immunogenicity of TAK-003, with the primary objective of assessing the vaccine-induced antibody levels to all four types of dengue virus following different vaccine schedules.
The study involves 1,794 children and adolescents ages 2 through 17 living in dengue-endemic territories, to be specific the Dominican Republic, Panama, and the Philippines. Consistent with information from past clinical examinations, TAK-003 was observed to be safe and well-tolerated in terms of solicited local reactions and systemic adverse events, relative to the placebo control group.
Overall vaccinated groups the immune response against all four dengue serotypes was durable. To the dengue virus with antibody levels enduring out to 18 months regardless of vaccine schedule or past exposure.
At the point when study members who had not been infected with dengue before were given a single dose of TAK-003, 69 percent demonstrated a positive antibody response against all four serotypes a half year after vaccination.
The second dosage at three months after the first dose improved the tetravalent seropositivity to 86 percent, while a booster dose at a year additionally increased the response to 100 percent.
In contrast, the first vaccine to be approved for dengue, Sanofi’s Dengvaxia, does not offer equal protection against all serotypes.
Currently against Dengue Efficacy Study (TIDES) TAK-003 is under evaluation in the Tetravalent Immunization, a large-scale Phase 3 efficacy trial being conducted in eight dengue-endemic nations.
“We are seeing an acceptable safety profile and sustained antibody responses out to the year and a half in this trial. In the development of our dengue vaccine candidate this information is an important step “, said Dr. Derek Wallace, Global Dengue Program Lead at Takeda
“In children and adolescents the reduced incidence of dengue getting TAK-003 is encouraging, however, information from our progressing Phase 3 efficacy trial, TIDES, are required to confirm these discoveries.”
TIDES will build on DEN-204 and other past examinations in proceeding to assess the tolerability, immunogenicity, and safety of the vaccine against all four four dengue serotypes in various age groups and to determine if the vaccine helps symptomatic dengue. Information from TIDES will be available in late 2018.