AgriLabs announced Nov. 13 U.S. Department of Agriculture conditional approval of the first DNA vaccine ever licensed for chickens.

The approval also represents the first for AgriLabs’ ExactVac DNA technology with ENABL adjuvant, the first DNA vaccine approved for influenza for veterinary use and among the first DNA vaccines approved in the U.S. for food animals.

The vaccine is produced by splicing a gene for a specific antigen related to a highly pathogenic avian influenza H5 subtype into a bacterial plasmid. The plasmid is then multiplied, purified and administered along with the ENABL adjuvant, which improves vaccine delivery into target cells, where antigens produced by the plasmid elicit an immune response.

The conditional license for highly pathogenic H5 will provide a tool for U.S. poultry producers if stockpiling is needed for future avian flu outbreaks. More broadly, this approval represents a significant step in development of an important new technology.

“This is a major milestone in realizing the promise of DNA vaccines in animal health,” said Steve Schram, president and chief executive officer of AgriLabs. “Past DNA research for vaccines for food animals has failed to deliver efficacy, cost and convenience. We believe ENABL adjuvant technology has unlocked the key to DNA vaccines. DNA vaccines offer tremendous potential, and our ENABL technology is unique in its ability to help realize that potential.”

According to Schram, DNA vaccines can be tools in the fight against important and emerging animal diseases — via rapid response in vaccine development and production that’s faster than conventional vaccines.

In addition, DNA vaccines are attractive in that they don’t expose the animals being treated to disease-producing organisms, and there is no risk of a modified pathogen mutating back to a virulent form, AgriLabs said. DNA vaccines also provide the ability to differentiate between infected and vaccinated animals.

ENABL adjuvant technology helps realize that promise through more efficient delivery of DNA-based vaccines, which results in a higher absorption of the DNA vaccine and production of antigen, as well as broader immune response, Schram said.

“ENABL adjuvants feature a patented lipid/polymer matrix that allows for effective dispersion of vaccine micro-particles and more efficient delivery to target cells,” Schram said. “In addition to creating a ‘micro-depot’ effect, this means reduced dosing for DNA vaccines, which makes them economically viable options.”

Opportunities for other species, licensing

The ExactVac DNA technology is applicable to other disease pathogens and animal species, including AgriLabs’ next targets of swine influenza and opportunities in cattle production. AgriLabs is seeking partners to license the DNA technology outside the U.S. market for both food and companion animals.

“The ExactVac DNA vaccine with ENABL adjuvant represents the next generation of biological innovation in animal health,” Schram said. “AgriLabs is proud to be delivering this DNA-based innovation -- which capitalizes on novel adjuvant technology and rapid-response diagnostics -- to the market.”

AgriLabs is a leader in biological innovation for animal health in the U.S. Through proprietary DNA and adjuvant technologies, AgriLabs is delivering the next generation of vaccine solutions for farm animals.