Human trial of plant-produced flu vaccine launched

Officials with Fraunhofer USA Center for Molecular Biotechnology recently announced the launch of the first human trial of a plant-produced H1N1 influenza vaccine.

The plant-based transient expression system for recombinant protein production has been developed over the course of the past eight years. Officials say the plant-based vaccine is a safe, fast and cost-effective alternative to traditional vaccine manufacturing.

Dr. Vidadi Yusibov, executive director of Fraunhofer USA CMB, said she was excited about the launch of the clinical trials.

“Moving to human trials is an important step which will demonstrate the utility of our unique production platform to produce much needed vaccines quickly to meet infectious disease threats,” Yusibov said. “This milestone has been achieved through the hard work and dedication of the Center’s staff along with the support of our Federal and State partners.”

Development of the vaccine funded by the Defense Advanced Research Projects Agency under a grant awarded in January. Fraunhofer officials filed an Investigational New Drug Application for the new vaccine with the Food and Drug Administration in August.

The purpose of the Phase 1 study, Yusibov said, is to determine the safety of the new vaccine and to determine appropriate dosage levels.

Yusibov said that the need for alternative manufacturing platforms with rapid response capability became apparent in the last year during the unpredicted emergence of the H1N1 influenza.