FDAnews
www.fdanews.com/articles/81587-vical-vaccine-enters-phase-ii-clinical-trial

VICAL VACCINE ENTERS PHASE II CLINICAL TRIAL

October 12, 2005

Vical has begun a NIH-sponsored Phase II clinical trial of a "prime-boost" vaccine approach against HIV. The trial involves priming an immune response with multiple doses of a plasmid DNA vaccine, based on Vical's proprietary DNA delivery technology, and boosting the response with a single dose of adenoviral vector vaccine given at a later date.

The vaccine incorporates HIV genetic material from the three most globally important HIV subtypes, clades A, B and C, which are involved in about 85 percent of all HIV infections around the world. Vical has produced multiple DNA vaccines against infectious diseases including Ebola, severe acute respiratory syndrome (SARS) and West Nile virus, all of which have advanced into Phase I clinical trials over the past two years. The new HIV vaccine trial is the first such program to advance an HIV DNA vaccine into Phase II trials.