Vaxart To Fight Norovirus in Children with Vaccine Candidate
Clinical-stage biotechnology company, Vaxart (Nasdaq: VXRT) has dosed the first subject in a Phase 1 clinical trial evaluating its oral pill bivalent norovirus vaccine candidate focused on lactating mothers.
Dr. James F. Cummings, Vaxart’s Chief Medical Officer, said, “Initiating this study is an important step toward Vaxart’s goal of developing a vaccine that may reduce the significant global health threat norovirus poses to children under 5 years of age. We believe an oral norovirus vaccine pill may make it possible for mothers to protect their infants against this highly contagious virus for which there currently is no approved vaccine.”
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 and their breast-feeding infants.
The study is expected to enroll approximately 76 subjects at seven sites in South Africa.
Norovirus sickens approximately 21 million people in the United States each year, and 15% of children under age 5 contract norovirus annually.
Pediatric deaths due to norovirus are rare in the US, but can be common in the developing world.
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.