Japan’s Takeda Pharmaceuticals Ltd. says the trial involves the first norovirus vaccine to ever enter human trials, although it will still take a number of years before a vaccine is ready for use, reports Food Safety News.
Rob Goodwin, vice president and global norovirus program head for Takeda Vaccines, said the first patient has received the TAK-214 vaccine in the phase IIb trial, which is due to enroll 3,400 patients and be completed in August 2017. Phase IIb is a double-Blind, randomized, placebo-controlled trial that will evaluate the efficacy and safety of the vaccine in healthy adults aged 18 to 49 years.
Norovirus, commonly called the “winter vomiting bug,” has been around since the 1920s. Today, about 30 genotypes of the norovirus have been identified and the virus is the leading cause of acute gastroenteritis in 700 million people worldwide every year. Of that number, about 200,000 will die, most of them children.
Norovirus is extremely contagious, with symptoms that include stomach pain, nausea, vomiting, and diarrhea. While most illnesses clear up in a few days, some cases can become life-threatening. There is no known drug treatment available for the norovirus, so a vaccine would be a major step in controlling the spread of the disease.
Vaccine makers are most concerned with two groups of people who are most impacted by the norovirus, children under the age of five and older adults, aged 65 and over. The trials must show the vaccine will have an impact on the illness in different groups, such as eliminating the need for hospitalization.
Takeda expects the norovirus vaccine will work more like the protection against rotavirus than a flu shot. Flu vaccines need to be prepared every year to include new strains of the virus, whereas rotavirus vaccines have a broader span of effectiveness. Takeda’s vaccine has shown itself to be effective for one year, but the company wants to see if it will be effective for longer periods of time.
“Together with our collaborators, Takeda has dedicated substantial scientific effort to understanding the best ways to prevent norovirus through vaccination, “Goodwin said. “This trial moves us one step closer to putting an important tool for prevention in the hands of individuals, families and public health systems around the globe.”
