GSK Begins Clinical Trials of Two H5N1 Vaccines

April 6, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

GSK Begins Clinical Trials of Two H5N1 Vaccines

GlaxoSmithKline (Philadelphia, PA, www.gsk.com) begun two clinical studies to test the safety and immunogenicity of two vaccines targeted against the H5N1 strain. Both vaccines are made from inactivated H5N1 virus, and various dose levels are being studied.

One trial in Germany, involving 400 volunteers, is testing a vaccine formulated with a classic alum. Researchers are testing whether the adjuvant will lower the amount of antigen needed per dose to stimulate an adequate immune response. The second clinical trial, conducted in Belgium and also involving 400 volunteers, is testing a vaccine formulated with a new adjuvant system. GSK investigators hope this vaccine will not only reduce the amount of antigen needed per dose, but also enable an immune response to various H5N1 strains, thereby providing broader protection.

The company expects to have preliminary clinical trial results in the third quarter of 2006.