Results from Influenza Challenge Study Published in Lancet Infectious Diseases

Efficacy of Oral Tablet Vaccine Compares Favorably to Market-Leading Fluzone

SOUTH SAN FRANCISCO, Calif., Jan. 22, 2020 (GLOBE NEWSWIRE) -- Vaxart, Inc. (VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines administered by tablet rather than by injection, announced today that the results from its H1 influenza oral tablet vaccine challenge study were published in the Lancet Infectious Diseases, January 21, 2020 and currently available at doi.org/10.1016/S1473-3099(19)30584-5. Topline results had been reported previously. 

The study demonstrated a single dose with the Vaxart oral tablet H1 influenza vaccine was well tolerated and provided statistically significant protection against H1 influenza infection in the human challenge model.   Efficacy results trended favorably when compared to Fluzone, an injectable quadrivalent influenza vaccine (QIV) and the active comparator in the study.

“If the results of the oral H1N1 influenza vaccine in this clinical trial can be reproduced with a quadrivalent mixture of strains this would revolutionize immunization against influenza, which after all is a mucosal disease,” said Stanley Plotkin, MD.  

Dr. Stanley A. Plotkin is Emeritus Professor of the University of Pennsylvania and Adjunct Professor of the Johns Hopkins University. Dr. Plotkin has developed several vaccines including the rubella vaccine now in standard use throughout the world and a recently licensed pentavalent rotavirus vaccine. He has also been involved in other vaccine development programs including anthrax, oral polio, rabies, varicella, and cytomegalovirus.

“These results provide clinical proof-of-concept for Vaxart’s proprietary technology being able to make an oral vaccine that is at least as protective as Sanofi’s Fluzone,” said Sean Tucker, Ph.D., chief scientific officer of Vaxart. “The results of the clinical study also demonstrated that our oral tablet vaccine primarily protects through mucosal immunity, a potential key factor for improving influenza vaccine performance.”

Data from the Phase 2 influenza A challenge study demonstrated that Vaxart’s oral tablet influenza vaccine generated a 39 percent reduction in clinical disease relative to placebo, compared to a 27 percent reduction by Fluzone.   It also reduced infection rates by 47 percent, compared to 43 percent by Fluzone.  The tablet vaccine showed a favorable safety profile, similar to placebo.