TARGETED GENETICS REPORTS INTERIM SAFETY DATA ON HIV VACCINE

Targeted Genetics has presented interim results from a Phase I trial of tgAAC09, an investigational HIV/AIDS vaccine candidate based on recombinant adeno-associated virus vector serotype 2 (AAV2). The trials for tgAAC09 are being conducted in collaboration with the International AIDS Vaccine Initiative. The trial, enrolling healthy volunteers who are not infected with HIV, was conducted in Belgium and Germany and is ongoing in India. A second trial of tgAAC09 is ongoing in South Africa, Uganda and Zambia to evaluate a higher dose and to systematically evaluate the utility and optimal timing of boost vaccination.

The Phase I trial is the first ever to test a recombinant AAV2-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 was well-tolerated.

The trial is a double-blind, placebo-controlled study. The sites in Belgium and Germany enrolled 50 volunteers who were in good general health and not infected with HIV. The sites in India enrolled 30 healthy HIV-negative volunteers. Each volunteer received a single intramuscular injection into the upper arm. A subset of volunteers also received a second dose of the vaccine to determine if repeat dosing is safe, and if it boosts immune responses.