Vaxart has completed the topline analysis for the Phase 1 clinical trial evaluating Vaxart’s oral pill bivalent norovirus vaccine candidate. The trial was focused on lactating mothers. Antibodies to norovirus rose on average 4.0 fold for the G1.1 virus strain and 6.0 fold for the GII.4 virus strain in the breast milk of lactating mothers who received the Vaxart vaccine candidate in the high dose group. There were no vaccine-related serious adverse events and no dose-limiting pharmacotoxicity. There is no approved vaccine against norovirus, which sickens approximately 21 million people in the United States each year, including the 15% of children under age 5 who contract norovirus annually. Approximately 3 million sets of parents are forced by this virus to miss work – approximately 2.2 days on average – to care for their children. The annual disease burden from norovirus is $10.6 billion in the United States alone. Globally, norovirus has become the leading cause of pediatric gastroenteritis in health care settings in countries that have adopted a rotavirus vaccine program. Pediatric deaths in the United States due to norovirus are rare, but they are much more common in the developing world. This Phase I trial was conducted in South Africa , and partially funded by the Bill & Melinda Gates Foundation. More complete results, including other immunogenicity measures, will be reported in a future scientific manuscript.
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