FluINsure vaccine challenge trial started.

2003 JAN 1 - (NewsRx.com & NewsRx.net) -- ID Biomedical announced that it has begun a human influenza challenge trial of its intranasally delivered FluINsure vaccine.

The clinical trial site began intranasal immunization of study subjects and delivery of all initial doses is scheduled to be completed by the end of this week.

A total of 75 healthy adult volunteers will receive the FluINsure vaccine or a placebo in this randomized, double-blind and concurrent placebo-controlled study. The study subjects will be divided into three approximately equal groups, with one group receiving placebo, one group a single-dose regimen of active vaccine, and one group a two-dose regimen.

On or about 40 days postimmunization (January 3, 2002), study subjects will be admitted to an isolation unit for observation. Two days later, those who are free of any confounding symptoms of other viral respiratory infections will be challenged intranasally with a strain of the influenza virus.

The challenge phase will last 8 days, during which time study subjects will be observed for clinical symptoms, examined daily, and have nose and throat secretion samples taken to detect and quantitate any influenza virus present. Immunogenicity markers will also be measured, both before and after challenge. We expect that results from this study will be reported by mid February.

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