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www.fdanews.com/articles/69030-targeted-genetics-reports-preliminary-safety-data-from-hiv-vaccine-trial

Targeted Genetics Reports Preliminary Safety Data From HIV Vaccine Trial

February 22, 2005

Targeted Genetics has reported preliminary results from a Phase I trial of tgAAC09, an investigational recombinant adeno-associated viral vector (rAAV)-based HIV/AIDS vaccine candidate, enrolling healthy volunteers who are not infected with HIV.

The trial is being conducted in Belgium, Germany and India. The Phase I trial is the first to test a rAAV-based vaccine and is primarily designed to evaluate safety and tolerability of the vaccine at escalating dose levels, the company said.

The study is also designed to evaluate immune responses following vaccination. No safety concerns were identified and the vaccine was well-tolerated. In addition, a single administration of the vaccine at the doses evaluated in this initial study did not elicit significant immune responses.