In a world first, Takeda has initiated a clinical trial testing the potential of an experimental vaccine for norovirus, which is responsible for nearly three quarters of a billion illnesses and 219,000 deaths each year around the globe.
The Phase IIb, double-blind, randomised, placebo-controlled study will assess the efficacy of the candidate - via intramuscular administration - against moderate or severe acute gastroenteritis due to norovirus infection.
The vaccine uses virus-like particle antigens, which are proteins that precisely mimic the outer surface of norovirus. Virus-like particle vaccines against human papilloma virus and hepatitis B virus have already been widely approved by regulatory bodies, highlighting the promise of this approach.
Data from earlier Phase I and Phase II studies of Takeda's jab indicated that it 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, 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."