Dengue vaccine candidate: Takeda announces data from 18-month interim Phase 2 trial

Takeda Pharmaceutical Company Limited today announced that data from your 18-month interim research into the ongoing Phase 2 Living room-204 trial of their live, attenuated tetravalent dengue vaccine candidate, TAK-003 (also called TDV), happen to be printed in The Lancet Infectious Illnesses. The outcomes of this interim analysis, a pre-planned look at data from your ongoing trial, reveal that TAK-003 is connected with a decrease in the incidence of dengue in youngsters and adolescents. These data were also presented today at the American Society of Tropical Medicine and Hygiene Annual Meeting. Phase 3 data are needed to verify these bits of information.

This transmission electron micrograph (TEM) depicts a number of round, Dengue virus particles that were revealed in this tissue specimen/ CDCThis transmission electron micrograph (TEM) depicts numerous round, Dengue virus particles which were revealed within this tissue specimen/ CDC

The Phase 2 Living room-204 trial is ongoing and evaluating the security and immunogenicity of TAK-003 in 1,794 children and adolescents ages 2 through 17 residing in dengue-endemic areas (tobago, Panama and also the Philippines). The main purpose of the trial is to assess the vaccine-caused antibody levels to any or all four kinds of dengue virus following different vaccine schedules. Trial participants received each one primary dose of TAK-003, two primary doses of TAK-003 administered three several weeks apart, one primary dose of TAK-003 adopted with a booster dose twelve months later, or perhaps a placebo. Febrile surveillance and assessment of safety and immunogenicity continues with the 48-month study duration of the trial.

These interim results showed:

·         In the security set (the audience of participants who received a minumum of one dose of TAK-003 or placebo), children and adolescents who received TAK-003 were built with a relative chance of symptomatic dengue of .29 (95% CI: .13–0.72) when compared with children and adolescents within the placebo control group. Incidence of dengue would be a pre-specified secondary endpoint from the analysis.

·         TAK-003 was discovered to be safe and well-tolerated when it comes to solicited local reactions and systemic adverse occasions, in accordance with the placebo control group. This really is in line with data from previous Phase 1 and a pair of studies.

·         The immune response against all dengue serotypes was durable across all vaccinated groups, with antibody levels persisting to 18 several weeks no matter vaccine schedule or previous contact with the dengue virus.

·         There was limited improvement in geometric mean titers (GMTs) and seropositivity rates between individuals who received one primary dose and individuals who received two primary doses three several weeks apart, no matter serostatus. However, importantly, in participants who have been seronegative at baseline, another dose given at Month 3 improved the tetravalent seropositivity rate at Month 6 to 86%, when compared with 69% within the one-dose group. A booster dose at Month 12 led to one hundredPercent tetravalent seropositivity rate at Month 13 in participants who have been seronegative at baseline.

These bits of information support choice of a 2-dose regimen, administered three several weeks apart, for Takeda’s ongoing global pivotal Phase 3 effectiveness trial. This regimen rapidly achieves maximum reaction to all dengue serotypes no matter previous dengue exposure.

“We are seeing a suitable safety profile and sustained antibody responses to 18 several weeks within this trial. These data are an essential part of the introduction of our dengue vaccine candidate,” stated Derek Wallace, M.B.B.S., Global Dengue Program Lead at Takeda. “The reduced incidence of dengue in youngsters and adolescents receiving TAK-003 is encouraging, however data from your ongoing Phase 3 effectiveness trial, TIDES, are needed to verify these bits of information.Inches

TAK-003 is presently under evaluation within the Tetravalent Immunization against Dengue Effectiveness Study (TIDES), a sizable-scale Phase 3 effectiveness trial being conducted in eight dengue-endemic countries. TIDES will develop Living room-204 along with other previous studies in ongoing to evaluate the tolerability, safety and immunogenicity from the vaccine against all dengue serotypes in multiple age ranges and also to see whether the vaccine aids in preventing symptomatic dengue. Data from TIDES is going to be obtainable in late 2018.