Takeda Pharmaceutical Company Limited 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.3 It is estimated that norovirus causes nearly 700 million cases of illness3 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.9 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.”

The norovirus intramuscular GI.1 and GII.4 VLP vaccine candidate is designed to cover the two genogroups that cause the majority of illness in humans. It is the only clinical-stage vaccine against norovirus under investigation at this time. Takeda has published results of a phase 1/2 challenge study, which showed that the candidate vaccine is generally well-tolerated, and had a clinically relevant impact on the symptoms and severity of norovirus illness after challenge.

Norovirus causes approximately 90 per cent of epidemic non-bacterial outbreaks of acute infectious gastroenteritis around the world. Norovirus is a common intestinal infection marked by watery diarrhea, vomiting, abdominal cramps, nausea and sometimes fever. Notably, most cases are endemic, occurring separate from outbreaks. According to U.S. Centers for Disease Control and Prevention (CDC) estimates, on average, people will experience four to five episodes of norovirus in their life. The virus typically is transmitted by the fecal-oral route, by aerosol or the environment, and by person-to-person contact, either directly or through contaminated food or water. Wherever people gather there is an increased risk. This includes the military, travelers, students living in dormitories, infants in child care, restaurants, hospitality and health care environments. Norovirus gastroenteritis can have a significant impact in all age groups, but most importantly in older adults and young children, and may lead to severe complications including death. Currently, there is no commercially available vaccine for norovirus.