Bozeman, MT-based LigoCyte Pharmaceuticals announced that a Phase I/II trial of the company's vaccine protected recipients from norovirus infection, commonly referred to as the "stomach flu." The study results were released today in The New England Journal of Medicine.
LigoCyte's intranasal vaccine, a dry powder formulation, uses virus-like particle (VPL) antigens to mimic the actual virus without causing sickness. LigoCyte recruited 90 subjects and dosed some of them with two rounds of the vaccine at 0 and 21 days. After 42 days, people in both the control arm and the vaccine arm were exposed to live norovirus, and then observed for four days after the exposure.
Of the 77 subjects who completed the trial, LigoCyte says its vaccine decreased gastroenteritis due to norovirus from 69.2% to 36.8%--a 47% drop in illness compared with people who didn't get the vaccine. Additionally, those who got the vaccine but still contracted the virus scored lower on a severity of illness scale.
According to LigoCyte's release, norovirus causes nausea, vomiting, abdominal cramps and diarrhea and infects 21 million people in the U.S. alone each year. Outbreaks hit hospitals, hotels, schools, day care facilities, nursing homes and military units particularly hard. Young children and older adults may have a particularly difficult time recovering from the disease.
"The positive results from this rigorous challenge study demonstrate that norovirus gastroenteritis, which can result in severe illness in many people, can be prevented by vaccination," said LigoCyte CEO Donald Beeman. "Development of our bivalent intramuscular vaccine is currently under way, and we look forward to the results of upcoming clinical studies of the product."
- here's LigoCyte's release