Takeda Pharmaceutical Company Limited today announced that it has dosed the first subject in a Phase 2b field efficacy trial of Takeda’s norovirus vaccine candidate (TAK-214), the only norovirus vaccine candidate in human clinical trials.


The Phase 2b, double-blind, randomized, placebo-controlled trial involves healthy male or female adults aged 18 – 49 years. It will evaluate the efficacy of intramuscular administration of Takeda’s norovirus vaccine candidate against moderate or severe acute gastroenteritis (AGE) due to norovirus, a common intestinal infection marked by watery diarrhea, vomiting, abdominal cramps, nausea and sometimes fever that may lead to clinically significant dehydration.

Norovirus is recognized as the leading cause of acute gastroenteritis across the age spectrum. It is estimated that norovirus causes nearly 700 million cases of illness with significant morbidity and social burden worldwide. More than 200,000 deaths per year are estimated to result from norovirus illness, primarily in low-income countries.

“We are excited to be on the frontline of development of a vaccine against norovirus,” said Rajeev Venkayya, MD, President of Takeda Vaccines. “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.”

The vaccine candidate uses virus-like particle (VLP) antigens, which are proteins that precisely mimic the outer surface of norovirus. The vaccine includes antigens from genotypes GI.1 and GII.4, to represent both of the genogroups that cause the majority of human illness. Virus-like particle vaccines against human papilloma virus and hepatitis B virus have been licensed by major regulatory bodies including the U.S. Food and Drug Administration, the European Medicines Agency and the Japanese Ministry of Health, Labour and Welfare. Results from Phase 1 and Phase 2 studies of Takeda’s norovirus vaccine candidate showed the vaccine is generally well-tolerated and was associated with a reduction in disease symptoms and severity in a human challenge study, which evaluated healthy adults’ responses following exposure to live norovirus.

“Together with our collaborators, Takeda has dedicated a substantial scientific effort to understand the best ways to prevent norovirus illness through vaccination,” said Robert Goodwin, PhD., Vice President and Global Norovirus Program Head for Takeda Vaccines. “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.”