Fraunhofer USA Center for Molecular Biotechnology (CMB) announced today it has received approval from the Food and Drug Administration to proceed with the first human clinical trial of plant-produced H5N1 influenza vaccine.
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.
Development of the H5N1 vaccine was funded by an $8.7 million grant from the Bill and Melinda Gates Foundation awarded November, 2008 as part of its efforts to improve global health by supporting creation of critical platform technologies for delivering vaccines to developing countries.
Fraunhofer filed an Investigational New Drug Application (IND) for its plant-derived H5N1 vaccine with the Food and Drug Administration on October 14, 2010. 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 H5N1 influenza was first reported in China in 1996 and the number of infections has increased since that time in both avian species and humans. As of December, 2009, the World Health Organization had documented 447 human cases which resulted in the deaths of 263 people. The H5N1 virus is now considered endemic in poultry and migratory bird populations in many parts of the world and is a possible candidate to cause the next influenza pandemic. Vaccination is considered the best option for preventing the spread of potentially pandemic viruses.
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