Takeda commences first ever norovirus vaccine field trial

Takeda has announced the commencement of a new field efficacy trial of its norovirus vaccine candidate TAK-214.

The company has dosed the first subject in the study, which represents the world's first norovirus vaccine field trial. The phase IIb study involves healthy male or female adults aged 18 to 49 years, and will evaluate the efficacy of intramuscular administration of the vaccine candidate against moderate or severe acute gastroenteritis due to norovirus.

Designed to cover the two genogroups that cause the majority of illness in humans, the intramuscular GI.1 and GII.4 VLP vaccine candidate is the only clinical-stage vaccine against norovirus under investigation at this time.

Norovirus is recognised as the leading cause of acute gastroenteritis across all age groups. The virus causes nearly 700 million cases of illness, with significant morbidity and social burden worldwide.

Dr Rajeev Venkayya, president of Takeda Vaccines, 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."

Results from an earlier phase I/II challenge study showed the candidate vaccine is generally well-tolerated, with a clinically relevant impact on the symptoms and severity of norovirus illness.