Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, announced Tuesday the initiation of a Phase 1 clinical trial of the first oral norovirus tablet vaccine.


“The start of the norovirus Phase 1 study is another important milestone for Vaxart’s oral vaccine platform,” said Wouter Latour, M.D., chief executive officer (CEO) of Vaxart. “We now have tablet vaccines in the clinic for norovirus, RSV and seasonal flu, three important pathogens with significant public health impact. A tablet vaccine for any of these indications would dramatically increase the efficiency of large vaccination campaigns – improving vaccine uptake and reducing costs. Having all three would be the ultimate trifecta in the vaccine sector.”

The randomized, double-blind, placebo-controlled Phase 1 dose-ranging study will assess the safety and immunogenicity of Vaxart’s VP1 protein-based norovirus tablet vaccine in 66 healthy adult volunteers. Study participants will be followed for 12 months for safety, and a broad range of systemic and local immune responses will be evaluated at multiple time points over the study.

“Norovirus is a significant public health concern, and there is increasing awareness of its medical burden and associated costs,” said Sean Tucker, Ph.D., founder and chief scientific officer (CSO) of Vaxart. “A tablet vaccine would be ideal for immunizing large populations, starting with the elderly and at-risk adults where norovirus causes considerable disease and mortality. “Since our vaccine is expected to generate systemic and local immune responses in the gut as it is administered orally by tablet, we believe it is the optimal approach to protect against norovirus.”