GSK initiates avian flu H5N1 vacc trial program

UK drug major GlaxoSmithKline has initiated a global clinical trial program to test two vaccines against the pandemic H5N1 strain of the avian influenza virus.

An evalutaion just initiated in 400 healthy adult volunteers in Germany is testing a vaccine using a classic alum adjuvant which might allow a lower amount of antigen to be used per dose. This trial supports a dossier GSK submitted to European regulators a few months ago (Marketletter January 16). Should a pandemic flu strain be identified by the World Health Organization, a variation to the dossier would allow rapid European registration and production of a vaccine against it. Another clinical evaluation being conducted in Belgium in 400 healthy adults is testing a candidate pandemic flu vaccine that contains a novel adjuvant system.

Both trials are testing the vaccine's safety and ability to boost individuals' immune response and will allow GSK to select an optimal dose and formulation for subsequent trials in groups at high risk of complications following influenza infection, such as children and the elderly.