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The New England Journal of Medicine Publishes Study Showing LigoCyte's Norovirus Vaccine Demonstrates Protection Against Illness
Date:12/8/2011

o 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

The Phase I/II randomized, double blind, multi-center, placebo-controlled safety and efficacy study was designed to evaluate the norovirus monovalent GI.1 VLP vaccine versus placebo in healthy adult volunteers between the ages of 18 and 50 years. The study consisted of two stages: the vaccination stage with post-vaccination follow-up, followed by the challenge stage, in which subjects were exposed to the live virus, with post-challenge follow-up. Subjects received a two-dose intranasal regimen of either the vaccine or placebo on days 0 and 21 and were evaluated for vaccine safety and immune responses. On or after study day 42, subjects were admitted to an inpatient nursing unit, challenged with live norovirus, held in the unit for at least four days following challenge and then followed for post-challenge safety and efficacy with multiple clinical assessments and collection of stool specimens. The study was conducted at Baylor College of Medicine, the University of Cincinnati and Cincinnati Children's Hospital Medical Center, the Johns Hopkins School of Medicine and SNBL CPC, Inc., a clinical research organization in Baltimore, Md.

About LigoCyte's Norovirus Vaccine Candidate

LigoCyte's norovirus vaccine contains virus-like particle (VLP) antigens representing the live virus while lacking the ability to reproduce or cause illness. VLPs mimic the natural virus by preserving the authentic structure of the viral capsid, the shell of protein that protects the nucleic acid of a virus. LigoCyte's VLP technology enables the production of vacc
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SOURCE LigoCyte Pharmaceuticals, Inc.
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