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Investigational norovirus vaccine found safe, effective

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SAN FRANCISCO — An investigational vaccine reduced the primary symptoms of norovirus by more than 50% in adult patients and was generally well-tolerated, according to new study results presented here at ID WEEK 2013.

"We found that the vaccine appeared to be safe — always the most important criteria — and that there was protection from vomiting and diarrhea, which are the most common symptoms of norovirus infection," David I. Bernstein, MD, professor of pediatrics at Cincinnati Children's Hospital Medical Center, said during a press conference.

 

David I. Bernstein

Bernstein and colleagues conducted a randomized, double blind, placebo-controlled trial of adults aged 18 to 50 years. Fifty participants received an injection of the bivalent vaccine and 48 received a placebo. The vaccine candidate, which contains virus-like particle antigens that resemble the virus but cannot replicate the illness, targets the GI.1 and GII.4 genotypes. GII.4 accounts for approximately 60% of current norovirus illness in the United States. The researchers collected stool samples up to 30 days after participants received their treatment.

Of those who received the vaccine, 52% were infected with the virus, whereas 60.4% in the control group had the infection. Among those who received the vaccine, 20% reported mild to severe illness, compared with 41.7% in the control group, corresponding to a 52% reduction in vomiting and/or diarrhea (P=.028). Also, fewer participants who received the vaccine shed norovirus 10 days after receiving the vaccine (22.4% vs. 36.2%; P=.179).

According to Bernstein, the protection from the vaccine increased in more severe cases of the disease.

"If the vaccine continues to prove as effective as our initial results indicate, it could be used for specific populations or situations — in those at a higher risk of severe disease such as the elderly or at high risk for infection or transmission such as in day care, people going on a cruise, those in nursing homes or in the military," he said in a press release. "Or it could be offered to everyone, since all of us are exposed at one time or another."

For more information:

Bernstein DI. Abstract #LB2. Presented at: ID Week 2013; Oct. 2-6, 2013; San Francisco.

Disclosure: Takeda Pharmaceutical Company supplied the vaccine.