Vaxart Reports Positive Preliminary Data from the Phase 1b Trial of its Oral Norovirus Vaccine Candidates in Elderly Adults
Results support safety and immunogenicity of the vaccine candidate in the highly vulnerable elderly population
Preliminary boost study data also reported
Norovirus has been estimated to cost
Results of the trial show a robust immune response across all doses, with a dose-dependent production of IgA antibody secreting cells (ASCs), consistent with previous studies conducted in younger populations. The results also demonstrate that the vaccine candidate was well tolerated with a favorable safety profile.
These data support the continued development of Vaxart’s oral norovirus vaccine candidate in adult populations, including elderly adults, and add to the growing body of evidence supporting its clinical utility.
Norovirus is the leading cause of acute gastroenteritis that produces vomiting and diarrhea among people of all ages. The World Health Organization’s (
The virus causes up to 21 million cases, 109,000 hospitalizations and 900 deaths annually in
“Our norovirus vaccine candidate, the only investigational norovirus vaccine formulated for oral administration, is optimized for delivery to the gastrointestinal system, which is the site at which norovirus enters the body,” said
Key findings from the Phase 1b study in elderly patients include:
- Robust immune response across all doses, with a dose dependent IgA ASC response
- IgA ASC responses were consistent with previous studies in younger subjects
- All solicited adverse events were mild or moderate with generally similar rates of events between the vaccine groups and placebo
“The results reported today support the potential of our Norovirus vaccine candidate in key patient populations and in a variety of boosting schedules,” said
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 tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet 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 tablet 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.
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Source: Vaxart, Inc.