Japanese-based pharmaceutical company Takeda has commenced the Phase IIb field trial of its norovirus vaccine candidate TAK-214 by dosing the first patient.
The double-blind, randomised and placebo-controlled Phase IIb trial involves healthy male or female adult subjects aged between 18 to 49 years.
The trial has been designed to evaluate the efficacy of Takeda’s norovirus vaccine candidate, TAK-214, when it is intramuscularly administered against moderate or severe acute gastroenteritis (AGE) due to norovirus.
Takeda Vaccines president Rajeev Venkayya said: "The progress of our norovirus programme, 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."
Norovirus is a common intestinal infection causing watery diarrhea, vomiting, abdominal cramps, nausea and sometimes fever.
The transmission of the virus is done by the fecal-oral route, by aerosol or the environment, and by person-to-person contact, either directly or through contaminated food or water.
Takeda’s TAK-214 uses virus-like particle (VLP) antigens, which are proteins that replicates the outer surface of norovirus.
The vaccine consists of antigens derived from genotypes GI.1 and GII.4, to represent both of the genogroups that is responsible for most of the human ailments.
The initial Phase I and Phase II studies of TAK-214 has demonstrated its tolerability and its ability to reduce the disease symptoms associated with a norovirus infection.
Image: Transmission electron micrograph displaying norovirus in faeces sample. Photo: courtesy of Graham Beards.