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NEJM publishes study showing LigoCyte's norovirus vaccine demonstrates protection against illness
Date:12/7/2011

ming clinical studies of the product."

Specifically, data from the study show:

  • In the 77 adults who completed the trial per its original protocol, vaccination decreased the incidence of gastroenteritis due to norovirus from 69.2 percent to 36.8 percent, a 47 percent reduction in illness compared to subjects receiving placebo (95% CI 15.2%-66.6%; p=.006).

  • Subjects receiving vaccine scored lower on a severity of illness scale (p=.011).

  • Immunization with the VLP vaccine increased antibody titers that blocked VLP binding to histo blood group antigens in vitro.

  • Higher functional antibody responses in all subjects correlated with increased protection against illness. A serum BT50 titer of 200 or greater was associated with a 72.2 percent reduction in virus-associated illness (odds ratio of 8.1 (95% CI 2.1-31.2)).

  • Adverse events occurred with similar frequency among vaccine and placebo subjects. The most common symptoms after vaccination included nasal congestion, stuffiness and sneezing.

About Norovirus Illness

Norovirus gastroenteritis is a widespread and potentially severe illness characterized by the acute onset of nausea, vomiting, abdominal cramps, diarrhea and occasionally fever. Noroviruses are highly infective and easily transmitted from person to person or via contaminated environments. Epidemic outbreaks occur in community environments, particularly hospitals, hotels, schools, day care facilities and nursing homes, with mounting socioeconomic cost to families, the health care system and businesses. Military units are significantly affected when the virus strikes, as outbreaks impact combat readiness. Severe clinical outcomes are reported in older adults, children and immunocompromised individuals in whom infection can lead to substantial complications and can even lead to death.

About the Phase I/II Norovirus Vaccine and Challenge Study

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Contact: Kari Watson
kwatson@macbiocom.com
781-235-3060
MacDougall Biomedical Communications, Inc.
Source:Eurekalert

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