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

P>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 approximately 90 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 Intranasal Norovirus Vaccine Candidate

LigoCyte's intranasal norovirus vaccine is a dry powder formulation containing 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 vaccine formulation also includes the adjuvant Monophosphoryl Lipid A, provided under license from GlaxoSmithKline PLC (NYSE: GSK), and the nasal vaccine incorporates chitosan. This application of chitosan (ChiSys) has been licensed from Archimedes Development Ltd.(1)

A clinical study of an intramuscular bivalent formulation of LigoCyte's norovirus vaccine is ongoing. Preliminar
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Contact: Kari Watson
kwatson@macbiocom.com
781-235-3060
MacDougall Biomedical Communications, Inc.
Source:Eurekalert

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