Vaxart shares topline data from phase 2 study of norovirus vaccine candidate
Vaxart has announced topline data from its phase 2 challenge study which assessed its oral tablet monovalent norovirus vaccine candidate. The study met five out of its six primary endpoints and the vaccine was safe and well tolerated with no vaccine-related serious adverse events reported.
The study enrolled 165 healthy adult patients who were randomised to either receive the vaccine candidate or a placebo. Four weeks after vaccination, patients were exposed to norovirus; the study met its primary endpoints of a statistically significant 29% reduction in the rate of norovirus infection between the vaccinated and placebo groups at day eight. Other endpoints that were met include a strong induction of norovirus-specific immunoglobulin A and immunoglobulin G antibodies and other immune response endpoints.
The study also demonstrated an 85% decrease in viral shedding in the vaccine group compared to placebo.
Dr James F Cummings, chief medical officer at Vaxart, commented: “Challenge studies use higher quantities of virus than an individual may encounter during a naturally occurring infection, yet our vaccine candidate demonstrated a significant effect on infection and viral shedding, even though it did not achieve a statistically significant reduction in norovirus AGE. The magnitude of the reduction in shedding could have an impact on transmission and may have important public health benefits, as norovirus spreads rapidly among people gathering in large numbers, including settings such as daycare centers, nursing homes and workplaces, and may reduce the potential spread of the infection to families at home.”
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