CMB initiates first human trial for plant-produced H1N1 influenza vaccine

Fraunhofer USA Center for Molecular Biotechnology (CMB) announced today it has initiated the first human trial of plant-produced H1N1 influenza vaccine at the Walter Reed Army Institute of Research Clinical Trials Center (WRAIR-CTC).

“Contributing to the success of this technology represents another important step to fulfilling our mission to conduct global medical research and deliver lifesaving products.”

Fraunhofer CMB's new, plant-based transient expression system for recombinant protein production has been developed over the past eight years as a safe, fast and cost-effective alternative to traditional vaccine manufacturing. The new platform technology has progressed from concept through technical innovations, process improvement, and scale up. Fraunhofer CMB produced the material for the clinical study in its recently completed pilot manufacturing facility in Newark, Delaware.

Dr. Vidadi Yusibov, Executive Director of Fraunhofer USA CMB stated "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. 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 H1N1 vaccine was funded by the Defense Advanced Research Projects Agency (DARPA) under a grant awarded to CMB in January. Fraunhofer filed an Investigational New Drug Application (IND) for its plant-derived H1N1 vaccine with the Food and Drug Administration on August 11, 2010. The purpose of the Phase 1 study is to determine safety of the new vaccine along with appropriate dosage levels.

"The WRAIR CTC is proud to work on this important effort with our valued partners," said LTC James F. Cummings, Director, Regulated Activities, WRAIR. "Contributing to the success of this technology represents another important step to fulfilling our mission to conduct global medical research and deliver lifesaving products."

The need for alternative manufacturing platforms with rapid response capability became apparent in the past year with the unpredicted emergence of the H1N1 influenza. DARPA's interest in developing advanced manufacturing technologies for vaccine production stems from the need to protect military personnel and civilian populations from infections agents.