Takeda starts world’s first norovirus vaccine field trial

The company dosed the first subject in a phase 2b double-blind, randomized, placebo-controlled trial of its norovirus vaccine candidate, TAK-214, which will target the leading cause of acute gastroenteritis across the globe.

Under the trial, which includes healthy male or female adults aged 18 to 49 years, the efficacy of intramuscular administration of TAK-214 will be assessed against moderate or severe acute gastroenteritis (AGE) due to norovirus.

Norovirus is a common intestinal infection characterized by watery diarrhea, vomiting, abdominal cramps, nausea and sometimes fever that could result in clinically significant dehydration.

Takeda Vaccines president Rajeev Venkayya said: "We are excited to be on the frontline of development of a vaccine against norovirus.

"The progress of our norovirus program, along with our efforts in dengue, polio and hand foot and mouth disease, demonstrates our commitment to tackling important infectious diseases that affect populations everywhere."

TAK-214 utilizes virus-like particle antigens, which are proteins that mimic the outer surface of norovirus.

It also includes antigens from genotypes GI.1 and GII.4, to represent both of the genogroups that lead to the most of human illness.

Results from phase 1 and phase 2 trials of TAK-214 demonstrated that the vaccine is generally well-tolerated.

It has also reduced disease symptoms and severity in a human challenge study, which assessed healthy adults’ responses after exposure to live norovirus.

Image: Takeda Midosuji Building, headquarters of Takeda Pharmaceutical Company, in Chuo-ku, Osaka, Japan. Photo: courtesy of J o.