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news.The Food and Drug Administration has approved Fraunhofer USA Center for Molecular Biotechnology (CMB) to begin human clinical trial of plant-produced H5N1 influenza vaccine.
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Fraunhofer said that the purpose of the Phase 1 study is to determine safety of the new vaccine along with appropriate dosage levels.
In the trial, the new vaccine will be tested in 260 healthy adult volunteers 18-49 years of age to determine safety and appropriate dosage levels.
Fraunhofer CMB produced the material for the clinical study in its recently completed pilot manufacturing facility in Newark, Delaware.
Fraunhofer filed an investigational new drug application (IND) for its plant-derived H5N1 vaccine with the Food and Drug Administration on 14 October 2010.