ABSTRACT.
dengue, infection
DENGUE, WEST, INFECTION, REINFECTION, DEL
These authors contributed equally to this work.Financial support: This study was sponsored by Takeda (Boston, MA). Editorial support was provided by Jenny Engelmoer (Sula Communications, Utrecht, Netherlands) and Miranda Dixon (Excel Medical Affairs, Horsham, West Sussex, United Kingdom), and funded by Takeda.Disclosure: S. B., M. L., D. W., N. F., and I. L. are permanent employees of the Takeda group of companies. S. B. and N. F. hold stock in Takeda. D. W. has patents WO2017/179017 and WO2020/051334 pending. X. S.- L. has received a research grant from Takeda to conduct the phase 3 trial and has participated in advisory boards of Takeda.Authors’ addresses: Xavier Sáez-Llorens, Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at SENACYT, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama, E-mail: 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.