Effect of the Tetravalent Dengue Vaccine TAK-003 on Sequential Episodes of Symptomatic Dengue

Am J Trop Med Hyg. 2023 Mar 6;108(4):722-726. doi: 10.4269/ajtmh.22-0673. Print 2023 Apr 5.

Abstract

In the pivotal phase 3 efficacy trial (NCT02747927) of the TAK-003 dengue vaccine, 5 of 13,380 TAK-003 recipients and 13 of 6,687 placebo recipients experienced two episodes of symptomatic dengue between the first dose and the end of the study, ∼57 months later (patients received the second dose 3 months after the first dose). Two of these participants experienced repeat infection with the same serotype (i.e., homotypic reinfection). In comparison with placebo, the relative risk of a subsequent episode of symptomatic dengue was 0.19 (95% CI, 0.07-0.54) in TAK-003 recipients. Based on the small number of subsequent episodes, these data suggest a potential incremental effect of TAK-003 beyond prevention of the first episode of symptomatic dengue after vaccination.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Viral
  • Dengue Vaccines*
  • Dengue*
  • Double-Blind Method
  • Humans
  • Serogroup
  • Vaccination

Substances

  • Antibodies, Viral
  • Dengue Vaccines

Associated data

  • ClinicalTrials.gov/NCT02747927