Targeted Genetics notes modest immune response in HIV vaccine trial; to release interim results

By Elaine Rigoli

Tampa, Fla., Aug. 30 - Targeted Genetics Corp. said that no safety concerns were identified during its phase 1 clinical trial of tgAAC09, an investigational HIV/AIDS vaccine candidate based on recombinant adeno-associated virus vector serotype 2, and that the vaccine was well tolerated.

Additionally, modest immune responses were observed in a subset of the volunteers receiving a single administration of the highest dose of the vaccine.

The company said this phase 1 trial is the first to test a recombinant adeno-associated virus vector-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.

Further studies are planned to determine the clinical relevance of the modest immune responses so far observed, the company noted in a news release. Meanwhile, the company plans to release interim results from the phase 1 trial.

The trial is being conducted in collaboration with the International AIDS Vaccine Initiative and enrolled healthy volunteers who are not infected with HIV. The trial has concluded in Belgium and Germany and is ongoing in India.

A second clinical trial of tgAAC09 is ongoing in South Africa, Uganda and Zambia to evaluate a higher dose of the vaccine and to systematically evaluate the utility and optimal timing of boost vaccination.

Targeted Genetics is a biotechnology company located in Seattle.

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