Vaxart injects first subject in Phase 1 trial of its norovirus vaccine candidate in breastfeeding mothers

Trial to assess the ability of oral vaccine tablets to induce breast milk antibodies and transfer antibodies to young children

SOUTH SAN FRANCISCO, Calif., Nov. 2, 2023 (GLOBE NEWSWIRE) — Vaxart, Inc. (Nasdaq: VXRT) today announced that it has enrolled the first subject in its Phase 1 clinical trial. The trial is evaluating Vaxart’s oral pill bivalent norovirus vaccine candidate. About breastfeeding mothers.

“Initiating this study is an important step toward Vaxart’s goal of developing a vaccine that can reduce the significant global impact of norovirus in children under 5 years of age,” said Dr. James F. Cummings, Vaxart’s chief medical officer. Health Threat.” “We believe an oral norovirus vaccine pill may allow mothers to protect their babies from this highly contagious virus, for which there is currently no approved vaccine.”

Norovirus affects approximately 21 million people in the United States each year, and 15% of children under 5 years old are infected with norovirus each year. This means that about 3 million parents need to take time off from work (about 2.2 days on average) to care for their children.

Globally, norovirus has become the leading cause of pediatric gastroenteritis in health care settings in countries with rotavirus vaccine programs.¹ Childhood deaths from norovirus are rare in the United States but are more common in developing countries.

About VXA-NVV-108 clinical trials

This Phase 1, multicenter, randomized, double-blind, placebo-controlled single-dose, dose-ranging study was designed to evaluate the safety, tolerability and immunity of an oral bivalent GI.1/GII.4 norovirus vaccine in healthy lactating women. Original sex is 18 years old and above and nursing infants (30 days to 11 months). The study is expected to recruit approximately 76 subjects across seven sites in South Africa. Subjects will be randomly divided into high-dose or low-dose vaccine groups (N=30 in each group) or placebo group (N=16). The primary endpoints are:

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• Frequency, duration, and severity of required reactogenic symptoms (local and systemic) within one week after study drug administration;

• Frequency, duration, and severity of active treatment-emergent adverse events (TEAEs), serious AEs (SAEs), adverse events of special concern (AESIs), and new-onset chronic conditions (NOCIs) throughout the active period (4 weeks post-dose) ;

• Serum VP1-specific (GI.1 and GII.4) IgA on day 1 (baseline), day 8, and day 29 (4 weeks after last dose);

• Breast milk VP1-specific (GI.1 and GII.4) IgA on day 1 (baseline), day 8, and day 29 (4 weeks after last dose).

¹ Shah and Hall, Infect Dis Clin North Am. 2018 Mar;32(1):103-118.

About vixter
Vaxart is a clinical-stage biotechnology company developing a pipeline of oral recombinant vaccines based on its proprietary delivery platform. The Vaxart vaccine is designed to be administered in a pill, allowing it to be stored and transported without refrigeration and eliminating the risk of needle stick injuries. Vaxart believes its proprietary pill-based vaccine delivery platform is suitable for delivering recombinant vaccines, allowing the company to develop oral versions of currently commercially available vaccines and design recombinant vaccines for new indications. Vaxart’s development program currently includes pill vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine against human papillomavirus (HPV), which is Vaxart’s first An immuno-oncology indication. Vaxart has filed extensive domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

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