Chicago-based biotech iBio has completed its first human trial of iBioLaunch-produced H1N1 influenza vaccine (HAC1) assessing safety, reactogenicity and immunogenicity.
The single-blind, placebo-controlled, dose escalation study—which began in September, 2010—confirmed the results of the June, 2011, announcement that HAC1 was safe and well tolerated at all dose levels, with or without adjuvant. There were no reported serious adverse events or dose-limiting toxicities, nor any subject withdrawals due to adverse events.
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 that was comparable with the immune response of the licensed, control H1N1 vaccine.
HAC1 was produced by iBio's research collaborator, the Fraunhofer USA Center for Molecular Biotechnology. 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).