NEWARK, Del.--(BUSINESS WIRE)--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 confirms the interim results from the first human trial of plant-produced H1N1 influenza vaccine (HAC1) that began 13 September, 2010 and ended 5 May, 2011. 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.
The final analyses confirm the results of the 2 June, 2011 announcement of the safety and immunogenicity of the HAC1 vaccine which was found to be safe and well tolerated at all dose levels, with or without adjuvant. There were no reported serious adverse events or dose-limiting toxicities. No subjects withdrew from the study as a consequence of an adverse event. The analyses also showed that the HAC1 vaccine elicited high levels of immune responses which correlated directly with the amount of antigen administered when the vaccine was not adjuvanted. The immune response was the highest in subjects who received the non-adjuvanted highest HAC1 dose which was comparable with the immune response of the licensed, control H1N1 vaccine.
A manuscript is under preparation to be published in a peer-reviewed journal.