Date: 2017-04-05
Type of
information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: Takeda Pharmaceutical (Japan)
Product: TAK-003 (live-attenuated tetravalent dengue vaccine candidate)
Action
mechanism:
- vaccine. TAK-003 is a tetravalent dengue vaccine candidate based on a live-attenuated dengue serotype 2 virus (DENV-2), which provides the genetic ‘backbone’ for all four vaccine viruses. Phase 1 data has been published in the Journal of Infectious Diseases, Lancet Infectious Diseases, and Vaccine. Interim results of DEN-203, a Phase 2, placebo-controlled, multi-center, age-descending trial, were presented during the American Society of Tropical Medicine and Hygiene (ASTMH) meeting in October 2015. Interim results of DEN-204, a Phase 2, placebo-controlled, multi-center trial were presented during the 5th Annual Pan-American Dengue Research Network Meeting in May 2016.
Disease: dengue fever
Therapeutic
area: Infectious diseases
Country: Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, Thailand, Vietnam, Peru
Trial
details:
- The purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants.
- The study is taking place in eight dengue-endemic countries in Latin America and Asia: Brazil, Colombia, Panama, Dominican Republic, Nicaragua, Philippines, Thailand and Sri Lanka.(NCT02747927)
Latest
news:
- • On April 5, 2017, Takeda Pharmaceutical announced that it has completed enrollment of 20,100 children and adolescents ages 4 through 16 in its global, pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial, a doubleblind, randomized and placebo-controlled study designed to evaluate the efficacy, safety and
immunogenicity of its live-attenuated tetravalent dengue vaccine candidate (TAK-003). Initial results of the TIDES trial are expected in 2018.
- • On September 7, 2016, Takeda Pharmaceutical Company announced that it has vaccinated the first subject in the Tetravalent Immunization against Dengue Efficacy Study (TIDES), a Phase 3 double-blind, randomized and placebo-controlled trial of its live-attenuated tetravalent dengue vaccine candidate (TAK-003).
- TIDES will enroll approximately 20,000 healthy children between the ages of four and 16 years living in dengue-endemic countries in Latin America and Asia. The study willevaluate the efficacy of the vaccine candidate to protect subjects against symptomatic dengue fever caused by any of the four dengue virus serotypes, regardless of age and whether the individual has previously been exposed to the virus. The study will also evaluate vaccine safety and immunogenicity, and will involve two doses of the vaccine candidate or placebo administered 90 days apart.
- TIDES will build on previous studies which have assessed the tolerability, safety and immunogenicity of the vaccine against all four dengue serotypes in multiple age groups to determine whether the vaccine helps prevent symptomatic dengue.5, 6, 7 In Phase 1 and Phase 2 studies, Takeda’s vaccine candidate induced neutralizing antibody responses against all four dengue virus serotypes across age groups and in both seropositive and seronegative individuals with no observed safety concerns. Interim results of one Phase 2 study (DEN-203) showed the vaccine to be generally safe and well tolerated.6 Results also showed that adults vaccinated with two doses had a sustained immune response against all four serotypes of the dengue virus, even after two years.6 Interim results of another Phase 2 study (DEN-204) 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 180 days.
Is
general: Yes
