1. In part 1, phase 3 of this randomized controlled trial, the overall vaccine efficacy of TAK-003 (dengue vaccine candidate) was approximately 80% among children ages 4 to 16 years old.
2. In addition, the vaccine increased the number of participants with seropositivity against dengue and showed to have significant efficacy against dengue leading to hospitalizations.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Dengue fever is a mosquito-borne viral illness that causes nausea, vomiting, rash, eye, muscle, joint, and bone pain. It was designated as a top 10 threat to global health in 2019 by the World Health Organization. This study represents a phase of an ongoing randomized trial of a new tetravalent dengue vaccine candidate (TAK-003). Healthy children and adolescents were split into a vaccine group and placebo group. The vaccine group was given two doses over a 3-month period and then virologically tested for the efficacy of preventing dengue fever. The vaccine was more efficacious against dengue fever when compared to the placebo group (0.5 per 100 person-years vs. 2.5 per 100 person-years). In addition, the vaccine group had a lower rate of hospitalizations and was most efficacious against the DENV-2 serotype. This trial is ongoing but is an important step in determining the efficacy of the new TAK-003 vaccine candidate given the global health threat of dengue fever. Further trials are needed to determine long-term safety and efficacy of this vaccine.