Production of candidate H5 influenza DNA plasmid based vaccine for human clinical trials has been completed in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials. The vaccine has been evaluated in healthy human volunteers in two Phase I clinical trials this (VRC 304 and VRC 305). If these trials demonstrate safety and immunogenicity of this vaccine in human trials, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials (CTM) at large scale.
|Stadinski, Brian D; Zhang, Li; Crawford, Frances et al. (2010) Diabetogenic T cells recognize insulin bound to IAg7 in an unexpected, weakly binding register. Proc Natl Acad Sci U S A 107:10978-83|