Fraunhofer USA Center for Molecular Biotechnology (CMB), a not-for-profit, Delaware-based organization focused on developing a proprietary plant-based protein production platform and its applications in vaccine and therapeutic fields, today announced positive interim results from the first human trial of plant-produced H1N1 influenza vaccine (HAC1) that began on September 13, 2010. This Phase 1, single-blind, placebo-controlled, dose-escalation study was conducted to assess the safety and reactogenicity and immunogenicity of CMB's HAC1.
The trial was supported by funding from the Defense Advanced Research Projects Agency (DARPA) and was conducted at the Walter Reed Army Institute of Research Clinical Trials Center (WRAIR-CTC). Safety and reactogenicity assessments were completed at WRAIR-CTC, and immunogenicity evaluation was performed by the Influenza Division of the Centers for Disease Control and Prevention.
"Successful completion of this Phase 1 safety and immunogenicity trial is a significant milestone in advancement of our proprietary technology and its applications," said Dr. Yusibov, Executive Director of Fraunhofer USA CMB.
Eighty healthy adult volunteers between 18 and 50 years of age were enrolled in the study and received two intramuscular doses of either CMB's vaccine or placebo, three weeks apart. A reference vaccine group received a single dose of an approved, monovalent H1N1 vaccine. To date, the new HAC1 influenza vaccine was found to be safe and well tolerated at all dose levels, with or without adjuvant. Immunogenicity of the vaccine was assessed using hemagglutination inhibition and virus microneutralization antibody assays. Preliminary serologic results showed that CMB's vaccine performed better in the absence of adjuvant. The level of immune response correlated directly to the amount of antigen volunteers received in a dose.
Dr. James F. Cummings, Director, Division of Regulated Activities at WRAIR stated:"Preliminary results of the trial are quite promising and indicate that clinical products are possible".
Completion of this Phase 1 trial is expected in the 2nd quarter of 2011 with final results available by the end of the year. The preliminary positive results warrant further development of CMB's new H1N1 plant-produced influenza vaccine.
About Fraunhofer USA CMB's H1N1 influenza vaccine candidate
CMB's HAC1 is the recombinant HA derived from the A/California/04/09 strain of influenza virus and produced in Nicotiana benthamiana plants using the proprietary "iBioLaunch" system. CMB's expression system for recombinant protein production has been developed over the past decade as a safe, fast and cost-effective protein production system. The new platform technology has progressed from concept through technical innovations, process improvement, and large scale production. CMB produced the material for the clinical study in its recently completed pilot manufacturing facility in Newark, Delaware.
Fraunhofer USA CMB