Ian Escudero, Dieter Gniel, Shibadas Biswal, Eckhardt Petri, Gonzalo Perez, Mayuri Sharma, John Weil, Derek Wallace
The approved, live-attenuated tetravalent dengue vaccine TAK-003 has undergone extensive preclinical and clinical assessment. This review provides an overview of the rationale for some key decisions made during TAK-003 development. These include decisions around vaccine composition, assessment of factors that may be associated with the safety of live-attenuated viral vaccines, dosing schedule, immunogenicity assessments, and design of the pivotal phase 3 efficacy study.