Takeda Begins Phase IIb Clinical Trial Of Norovirus Vaccine

The only vaccine currently in development to prevent norovirus infection has just entered a Phase IIb clinical trial. The developer of the vaccine – Takeda Pharmaceuticals – has started dosing patients to assess the efficacy of the norovirus vaccine candidate.

Norovirus is a highly-infectious intestinal illness which leads to diarrhea and vomiting. Much like other infectious diseases that cause these symptoms, norovirus can cause severe dehydration which has the potential to be fatal.

The Japan-based drugmaker’s intramuscular vaccine – known as TAK-214 – uses virus-like particles to mimic the antigen-coated surface of the norovirus. According to Takeda, an earlier clinical trial of the norovirus vaccine found that the drug was well tolerated among the 98 trial participants, but did not significantly reduce diarrhea or vomiting symptoms.

Norovirus is associated with approximately 20 percent of all cases of diarrheal disease worldwide, according to the Centers for Disease Control and Prevention (CDC). Their estimates suggest that the average person could expect to become ill from a norovirus infection between three and eight times in their lifetime.

As there is no approved drug to treat patients with norovirus, efforts have been focused on preventing transmission of the disease. Norovirus can be acquired from contact with infected individuals and contaminated food and surfaces.

Currently, there is no available vaccine to prevent norovirus infection. “We are excited to be on the frontline of development of a vaccine against norovirus,” said Rajeev Venkayya, president of Takeda Vaccines.

Around 3,400 participants will be enrolled in the Phase IIb clinical trial, according to Takeda. The company expects that the trial will run until August of 2017.