04 May Phase 2 Trial of Takeda’s Dengue Vaccine Demonstrates Immune Response Against All 4 Strains
MedicalResearch.com Interview with:
Dr Vianney Tricou DPhil
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Dengue fever is a painful, debilitating mosquito-borne disease caused by any one of four closely related dengue virus serotypes, and persons living in dengue endemic regions may be affected by dengue more than once in their lifetime. Some individuals with dengue fever are hospitalized and may need intensive therapy to prevent shock and death, and severe dengue is a leading cause of hospitalization and death among children and adults in some Asian and Latin American countries. About half of the world’s population lives under the threat of dengue and the disease has a significant medical and economic impact in the tropical and subtropical regions of the world where dengue is endemic.
Takeda is committed to improving global public health and to developing a life-saving dengue vaccine candidate for people around the world. Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus (DENV-2), which provides the genetic ‘backbone’ for all four attenuated dengue virus serotypes present in the vaccine. Takeda’s Phase 1 and Phase 2 clinical study program includes 8 studies to date that assess the safety and/or immunogenicity of this candidate, before moving into Phase 3.
Takeda’s ongoing Phase 2 DEN-204 study is designed to assess the safety and immunogenicity of one- and two-dose schedules of TAK-003 in 1,794 healthy children and adolescents ages two through 17 years living in dengue-endemic countries in Latin America and Asia.
As published in The Lancet Infectious Diseases in March 2017, an interim analysis of DEN-204 data indicated that TAK-003 elicited antibody responses to all four dengue serotypes in the population studied, regardless of whether they had previous dengue exposure.
A second TDV dose improved antibody responses against DENV-3 and DENV-4 in children who were seronegative before vaccination. In this study, the safety profile was consistent with that observed in earlier Phase 1 and 2 studies.
MedicalResearch.com: What should readers take away from your report?
Response: Safety and immunogenicity data from the DEN-204 interim analysis are encouraging across all serotypes, regardless of previous dengue exposure, and support the continued and expanded study of this vaccine candidate in a Phase 3 clinical study program, including in a large-scale safety and efficacy study in dengue endemic countries, in a two dose schedule.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: In Phase 1 and 2 studies, immunogenicity is measured by detecting the antibody response to each serotype, but, because there is no antibody correlate of protection, it will be necessary to study the protective efficacy and safety of this dengue vaccine candidate in a large-scale Phase 3 clinical study.
Our global, pivotal TIDES Phase 3 clinical trial, Takeda’s largest clinical trial to date, has been designed to assess whether two doses of Takeda’s dengue vaccine candidate can safely protect against all four strains of dengue in children and adolescents 4-16 years old, regardless of previous dengue exposure. Evaluation of the trial’s primary endpoint is expected in 2018.
MedicalResearch.com: Is there anything else you would like to add?
Response: Shortly after the publication of DEN-204 interim data in The Lancet Infectious Diseases, Takeda announced completion of enrollment of 20,100 children and adolescents ages 4 through 16 in our TIDES trial in less than seven months from study start. This is a significant milestone for Takeda as it is another step forward in the journey to develop and test a vaccine candidate for use in populations and individuals at risk of symptomatic dengue, regardless of whether they have previously been exposed to the virus.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Safety and immunogenicity of one versus two doses of Takeda’s tetravalent dengue vaccine in children in Asia and Latin America: interim results from a phase 2, randomised, placebo-controlled study
Sáez-Llorens, Xavier et al.
The Lancet Infectious Diseases , Volume 0 , Issue 0 ,
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