Oral Norovirus Vaccine Candidate Posts Positive Results
A biotechnology company announced positive results of the Phase 1 clinical trial with its norovirus oral tablet vaccine.
The primary immunological endpoint of the study, an increase in BT50 titers, was met in the high dose group with 78% of subjects showing a greater than or equal to twofold rise after a single immunization.
In addition, more than 80% of recipients of the high dose vaccine developed mucosally-primed norovirus specific circulating antibody secreting cells, IgA positive memory B cells expressing the α4β7 gut homing receptor, and fecal IgA.
This is important since there are no norovirus vaccines currently approved by the U.S. Food and Drug Administration.
“We believe our tablet vaccine could provide an optimal solution to help reduce the burden of disease in vulnerable populations, such as the elderly and the very young, as well as people at-risk in the healthcare, travel and food industry,” said David Taylor, M.D., chief medical officer of Vaxart.
“Norovirus causes substantial morbidity and mortality all across the globe, impacting populations of all ages in all walks of life,” said Dr. Taylor, in a press release.
The U.S. Centers for Disease Control and Prevention (CDC) estimates that norovirus causes 19 to 21 million illnesses in the United States each year, resulting in 56,000 to 71,000 hospitalizations and 570 to 800 deaths.
In a recent John Hopkins University study, researchers estimated healthcare costs of norovirus at $4.2 billion and lost productivity costs at $56.2 billion globally.
Norovirus is a common intestinal infection that typically lasts three to five days and is marked by watery diarrhea, vomiting, abdominal cramps, nausea and sometimes fever, says the CDC.
Symptoms can be more severe in older adults and young children and may lead to serious complications including death.
Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform. For more information, please visit vaxart.com.
- Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine
- VAXART ANNOUNCES PUBLICATION OF THE PHASE 1 RESULTS OF ITS ORAL NOROVIRUS TABLET
- Global Economic Burden of Norovirus Gastroenteritis
- Safety and immunogenicity of an oral tablet norovirus vaccine, a phase I randomized, placebo-controlled trial