TAK-003: development of a tetravalent dengue vaccine

INTRODUCTION: Dengue incidence has increased over the past few decades. One tetravalent dengue vaccine based on a yellow fever backbone has been approved, but due to increased risk of severe disease in dengue-naïve recipients, its use is limited to individuals with prior dengue exposure. AREAS COVERED: We summarize the clinical development of TAK-003, a tetravalent dengue vaccine based on a live-attenuated DENV-2 backbone. We discuss vaccine development and preclinical and clinical work leading to a commercially available formulation. TAK-003 is approved in several countries and the WHO-SAGE recommend TAK-003 to be considered for public programs in high transmission areas for individuals aged 6-16 years. Finally, we discuss the potential role of TAK-003 as part of an integrated multimodal strategy for dengue prevention. EXPERT OPINION: TAK-003 has been assessed in a comprehensive clinical development program; demonstrating sustained efficacy and safety against all four serotypes in baseline seropositive individuals, and against DENV-1 and DENV-2 in seronegative individuals, and has been well tolerated. Effectiveness in a real world setting and safety will be monitored in ongoing and future studies, particularly for DENV-3 and DENV-4, together with the impact of a booster dose. Overall, TAK-003 shows promise as a new tool for dengue prevention.