Bivalent Norovirus Vaccine Candidate Posts Positive Preliminary Data

Vaxart, Inc. recently announced positive topline data from the dose-ranging Phase 2 clinical trial of its oral pill bivalent norovirus vaccine candidate.

This study's preliminary results showed robust serum immune responses across all doses at Day 29 relative to Day 1.

Both doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms, and the mucosal and cell-based assay data will be available later.

Dr. James F. Cummings, Vaxart's Chief Medical Officer, commented in a press release on July 6, 2023, "These data, additional forthcoming data from this study, and the data we expect from our norovirus challenge study, will help inform our selection of dosage levels in a larger Phase 2b study."

"And support an End-of-Phase 2 meeting with the U.S. Food and Drug Administration."

"Our bivalent vaccine is designed to target the most important genogroups, GI and GII, and specifically to cover the important strains, GI.1 and GII.4. GII.4 currently causes the majority of norovirus disease in humans." 

This Phase 2 dose-ranging study demonstrated that the bivalent norovirus vaccine candidate was well tolerated, with a favorable safety profile.

This is the seventh clinical trial completed in Vaxart's norovirus program, and it supports previous findings of robust immunogenicity and benign tolerability. 

As of July 10, 2023, Vaxart's vaccine is one of several norovirus vaccine candidates conducting clinical research.

Norovirus is a very contagious virus that causes vomiting and diarrhea. Anyone can get infected and sick with norovirus. The U.S. Centers for Disease Control and Prevention (CDC) says norovirus cases generally occur most frequently during late fall, winter, and early spring.

The CDC publishes the Norovirus Outbreak Map and posts Norovirus National Trends.