Safety, Immunogenicity, and Efficacy of a Tetravalent Dengue Vaccine in Healthy Children

摘要

TAK-003 elicited antibody responses that persisted for 48 months; efficacy varied by serotype during 18 months offollow-up. The tetravalent dengue vaccine TAK-003 (Takeda Vaccines, Inc.) is based on a live-attenuated dengue serotype-2 virus (DENV-2) that provides the genetic backbone for all four dengue serotypes. Biswal and colleagues previously showed that TAK-003 was protective in children in dengue-endemic areas for 12 months after vaccination (NEJM JW Infect Dis Jan 2020 and N Engl J Med 2019; 381:2009). Now, those investigators and another team have completed two manufacturer-funded, randomized, double-blind, placebo-controlled trials to further assess the use of TAK-003 in healthy children. In the phase III Biswal study, approximately 20,000 children (aged 4-16 years) at 26 dengue-endemic centers in the Americas and Asia were randomized (2:1) to receive two doses of TAK-003 or placebo at 0 and 3 months. The primary endpoint (overall efficiency) was assessed during the 12 months of follow-up; secondary endpoints (efficacy against hospitalized dengue, serotype, and severe dengue) were assessed during 18 months of follow-up.