Takeda has recently finished enrolling 20,100 children for their phase 3 dengue vaccine clinical study in 8 endemic countries after just seven months.
The study, that was started back in September 2016, is a placebo controlled study covering two doses of the vaccine each three months apart in children aged from 4 to 16. The aim is to confirm if the vaccine can protect against any dengue serotype of varying severities regardless of previous exposure.
Takeda have committed over $100M to building a manufacturing plant for the vaccine product in Singen, Germany. Efficacy data is expected by 2018 says Derek Wallace that if positive will “set the stage for Takeda to have a major impact” on the hundreds of millions of dengue infections globally each year.
If approved the vaccine would be a competitor to Sanofi’s first to market Dengvaxia® which, despite 20 years of development and an investment exceeding $1.5B, has fallen short of the initial sales expectations. Takeda’s vaccine could potentially steal market share by 2020 with some industry experts predicting that Dengue vaccines will reach over $1billion in annual sales.
As it stands, Takeda’s vaccine has been through a number of previous clinical studies where it demonstrated good safety and immunogenicity against dengue’s four serotypes. Furthermore, Takeda is also working with the Bill & Melinda Gates Foundation to help eradicate Polio and the U.S. agency, BARDA, on a Zika vaccine programme.