Vical Incorporated announced the publication of data documenting the successful pilot lot production and initiation of animal immunogenicity testing of a Vaxfectin-adjuvanted DNA vaccine for H1N1 influenza before conventional vaccine manufacturers even received the seed virus needed to start production.

The US Navy has awarded a contract for US$ 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 US 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, 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 labour-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 article, which outlines the vaccine development process and timeline during the early stages of the emerging pandemic, was published in the newly reinaugurated international journal Gene Therapy and Regulation. A key point of the article is that the DNA vaccine technology uses consistent and predictable methods that could be applied with the same speed in future pandemics. The company has advanced directly to large-scale cGMP manufacturing of the vaccine for human clinical trials after securing external funding for this programme.

The company's vaccine against A/H1N1 pandemic influenza (swine flu) produced robust immune responses against the matching strain that were well above the accepted protection threshold in 100 per cent of vaccinated mice and rabbits after a standard two-dose vaccine regimen. At least 75 per cent of vaccinated animals achieved or exceeded the protection threshold after a single dose of vaccine. In further studies, the vaccine demonstrated robust immune responses in 100% of vaccinated animals against non-matching virus strains isolated from recent outbreaks in three distinct geographic locations - California, Texas and Mexico. Vical's vaccine would also be expected to provide similar robust immune responses against other swine-origin A/H1N1 influenza virus subtypes, supporting selection of a single A/H1N1 virus strain as the basis for the vaccine.

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.