The phase I trial is the first ever to test a recombinant adeno-associated viral vector (rAAV)-based vaccine and is primarily designed to evaluate safety and tolerability of the vaccine at escalating dose levels. The study is also designed to evaluate immune responses following vaccination.
No safety concerns were identified and the vaccine, tgAAC09, proved to be well tolerated in the healthy volunteers. In addition, a single administration of the vaccine at the doses evaluated in this initial study did not elicit significant immune responses.
“The favorable tolerability data from this trial are consistent with our growing clinical experience with AAV and now position us to continue the clinical development of this vaccine program,” said H. Stewart Parker, Targeted Genetics’ president and CEO. “We can begin to evaluate higher dose levels and repeat administration of this vaccine.”