Fraunhofer USA Gets FDA Go-Ahead for H5N1 Vaccine Trial

(Agricultural Research Service, USDA)

Fraunhofer USA Center for Molecular Biotechnology (CMB) in Newark, Delaware says it received approval from the U.S. Food and Drug Administration (FDA) to proceed with the first human clinical trial of its plant-produced H5N1 influenza — avian flu — vaccine. The research institute filed an Investigational New Drug Application for its plant-derived H5N1 vaccine with FDA on 14 October 2010.

Fraunhofer CMB developed over the past eight years a plant-based transient expression system for recombinant protein production, as an alternative to traditional vaccine manufacturing. Plants can be reprogrammed to cause the production of copious quantities of nano-particles, each with immunity-stimulating signals called epitopes on their surfaces. The institute says these nano-particles make it possible to quickly produce potent and safe vaccines.

The purpose of the Phase 1 study is to determine safety of the new vaccine along with appropriate dosage levels. The new vaccine will be tested in 260 healthy adult volunteers 18-49 years of age to determine safety and appropriate dosage levels.

The Bill and Melinda Gates Foundation funded development of the H5N1 vaccine with an $8.7 million grant awarded in November 2008.

Related: Baxter, Takeda Complete Deal on Influenza Vaccines

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