Takeda initiates world’s first norovirus vaccine field trial

Takeda 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...