Norovirus VLP intramuscular vaccine: Phase I/II data

A double-blind Phase I/II trial in 98 healthy volunteers aged 18-50 years showed that Norovirus VLP intramuscular vaccine missed the composite primary endpoint of reducing the incidence of acute gastroenteritis of any severity and norovirus as ascertained by laboratory assay vs. placebo. Specifically, the vaccine led to a 22% reduction on the endpoint compared to placebo (p=0.509). Takeda said that the illness definitions and measures used to confirm illness on the primary endpoint - a 4-fold increase in antibody titer and the presence of DNA in stool as measured by PCR - were unable to differentiate between infection and disease. Following challenge, 52% of subjects who received the vaccine were infected with the virus vs. 60.4% for placebo. ...