Vaxart, Inc. announced it has dosed the first subject in its Phase 1 clinical trial evaluating Vaxart?s oral pill bivalent norovirus vaccine candidate focused on lactating mothers. Norovirus sickens approximately 21 million people in the United States each year, and 15% of children under age 5 contract norovirus annually. This would translate into about 3 million sets of parents needing to take time from work (approximately 2.2 days on average) to care for their children.

Globally, in countries that have adopted a rotavirus vaccine program, norovirus has become the leading cause of pediatric gastroenteritis in health care settings. Pediatric deaths in the United States due to norovirus are rare, but they are much more common in the developing world. About the VXA-NVV-108 Clinical Trial: The Phase 1, multicenter, randomized, double-blind, placebo-controlled single dose, dose-ranging study is designed to evaluate the safety, tolerability, and immunogenicity of orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females of at least 18 years of age and their breast-feeding infants (aged 30 days to 11 months).

The study is expected to enroll approximately 76 subjects at seven sites in South Africa. Subjects will be randomized into high- or low-dose vaccine (N=30 for each arm) or placebo (N=16). The primary endpoints are: Frequency, duration and severity of solicited symptoms of reactogenicity (local and systemic) for one week following study drug dose; Frequency, duration and severity of unsolicited treatment-emergent adverse events (TEAEs), serious AEs (SAEs), adverse events of special interest (AESIs) and new onset of chronic illness (NOCIs) through the active period (four weeks post dose); Serum VP1-specific (GI.1 and GII.4) IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post last dose); Breastmilk VP1-specific (GI.1 and GII.4) IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post last dose).