Asian Scientist (Oct. 17, 2013) – Takeda Pharmaceutical Company has announced the results of a Phase 1/2 study of its intramuscular bivalent (GI/GII) norovirus vaccine candidate.
The vaccine was well-tolerated and people who were vaccinated had less severe disease following challenge with live norovirus, providing evidence for further investigation.
Norovirus gastroenteritis is most commonly associated with vomiting and diarrhea, and occurs in all age groups.
“Norovirus causes nearly 90 percent of epidemic non-bacterial outbreaks of gastroenteritis around the world, leading to as many as 71,000 hospitalizations each year in the U.S. alone,” said the study’s lead investigator Dr David I. Bernstein.
“There is a critical unmet medical need for a vaccine to combat this significant global health issue, and this vaccine candidate has the potential to address that need.”
The Phase 1/2 randomized, double blind, placebo-controlled multi-center study was conducted in 98 healthy adult volunteers, aged 18-50.
The volunteers, who were challenged with the most commonly occurring norovirus (genotype GII.4) that causes gastroenteritis, were able to tolerate two doses of the experimental bivalent norovirus well.
The results of the clinical trial further showed that the candidate vaccine had a clinically relevant impact on the incidence of norovirus illness after challenge, as well as the severity in breakthrough cases.
A statistically significant reduction in mild, moderate or severe vomiting and/or diarrhea was observed in vaccinated subjects. Although the total number of subjects with gastroenteritis symptoms was also reduced in the vaccine group, this reduction was not statistically significant.
In addition to the impact on clinical illness, a positive trend toward reduction in viral shedding in stool was also observed.
“This is the first time that vaccination with a norovirus candidate vaccine has resulted in a reduction of symptoms caused by experimental exposure to the most common strain of norovirus, genotype GII.4,” said Rajeev Venkayya, executive vice president and head of Takeda’s Vaccine Business Division.
“We are very encouraged by these findings, from one of the largest human challenge studies performed to date, which pave the way for further development of this first-in-class vaccine,”
The study also provided important information toward optimization of confirmatory lab testing for norovirus disease and infection in a future field trial.
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