The U.S. Navy has awarded a contract for $1.25 million to support large-scale cGMP vaccine manufacturing and related clinical and regulatory preparations for a Phase 1 clinical trial of the company's vaccine against H1N1 pandemic influenza. The trial will be conducted in collaboration with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the Navy, and is expected to begin within the next few weeks.
"DNA vaccines offer unprecedented speed in development and production," said Larry Smith, Ph.D., Vical's Vice President of Vaccine Research and an author on the paper, "and the 2009 outbreak of H1N1 pandemic influenza provided an opportunity to demonstrate the advantages of our approach. We do not have to handle the pathogen, and derive our vaccine instead from a gene sequence posted on the Internet. We can develop a vaccine quickly and match it exactly to the circulating pathogen, providing the greatest possible vaccine effectiveness. Our manufacturing process does not rely on chicken eggs or other time- and labor-intensive cell culture processes that require vaccine-specific facilities. We produce our vaccines through rapid and reliable bacterial fermentation. The inherent stability of DNA does not require the precise temperature control needed for conventional vaccines, and allows great flexibility in shipping and storage. In short, the DNA vaccine platform is well-suited to addressing emerging infectious disease threats even before they become pandemics." The vical press room offers complete study details