The effects of Dengue Vaccine in Healthy Children involving children and adolescents between the ages of 4 and 16

 

Dengue Vaccines
Dengue Vaccines

Dengue fever is a pandemic-prone viral disease whose prevalence has increased by a factor of 30 in the last 50 years. Nearly half of the world's population lives in dengue-endemic areas in more than 100 countries, with an estimated 390 million cases of dengue virus infection each year. Dengue fever can range from asymptomatic infection to severe disease with a 20% mortality rate if left untreated. Dengue virus serotypes through (DENV-1 through DENV-4) frequently cocirculate in endemic areas. Although the infecting serotype provides decades of protective immunity, secondary infection with a different serotype increases the risk of severe disease.

CYD-TDV (Dengvaxia, Sanofi Pasteur), a tetravalent dengue vaccine based on a yellow fever virus "backbone," has been licenced in several countries based on a 56 to 61 percent vaccine efficacy against virologically confirmed dengue in children in Asia and Latin America. Because CYD-TDV is associated with an increased risk of severe dengue and dengue leading to hospitalization in seronegative people, it is recommended that it be given only to people who have had a previous infection. This leaves a significant unmet need.

TAK-003 (Takeda) is a new tetravalent dengue vaccines candidate based on a live attenuated DENV-2 virus that serves as the genetic backbone for all four viruses in the vaccine, which were originally designed and constructed by scientists at the Centers for Disease Control and Prevention's Division of Vector-Borne Diseases (CDC). The DENV-2 strain (TDV-2) is based on DEN-2 primary dog kidney (PDK)-53, an attenuated laboratory-derived virus. The other three virus strains (TDV-1, TDV-3, and TDV-4) are chimaeras formed by replacing TDV-2's premembrane and envelope genes with those of wild-type DENV-1, DENV-3, and DENV-4 strains.

The efficacy, safety, and immunogenicity of two doses of TAK-003 are currently being evaluated in a large-scale, phase 3, randomised clinical trial involving children and adolescents aged 4 to 16 in Latin America and Asia (Efficacy, Safety, and Immunogenicity of Takeda's Tetravalent Dengue Vaccine in Healthy Children [TIDES]). We present the preliminary results of the first phase of this ongoing trial.

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