Osaka-based Takeda Pharmaceuticals has started dosing in its first field trial for a norovirus vaccine, boosting its lead efforts for a candidate to curb the virus that leads to gastroenteritis.
In a release, Takeda said the Phase IIb, placebo-controlled study is the only human clinical trial for a norovirus vaccine globally. It'll seek to assess TAK-214 for its efficacy and immunogenicity against moderate to severe acute norovirus in male and female patients 18 to 49 years old.
The trial will be conducted in the U.S. at military bases and recruit 2,800 to 8,700 subjects with a completion date in December 2017.
TAK-214 uses virus-like particle antigens and an aluminum adjuvant aimed at the two most common norovirus genotypes, GI.1 and GII.4. The candidate was bought in 2012 from LigoCyte Pharmaceuticals for $60 million.
“We are excited to be on the frontline of development of a vaccine against norovirus,” Rajeev Venkayya, president of Takeda Vaccines said in a statement.
Takeda has stepped up vaccine efforts, consolidating the vaccines business unit in Singapore in 2015 and developing in areas such as dengue, enterovirus 71 hand, foot and mouth disease with candidates bought from Inviragen.
Earlier human challenge studies for TAK-214 showed the vaccine well tolerated, but a 2013 result from an early-stage trial showed the vaccine missed its primary endpoint.
Norovirus cases clock in at around 700 million worldwide each year. It is especially acute in developing countries.
- here's the release from Takeda
Takeda's norovirus vaccine misses endpoint in early-phase trial