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news.Targeted Genetics Corporation has said that interim data from a Phase II trial of its investigational HIV vaccine in Africa has shown that the drug is safe and well-tolerated.
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The tgAAC09 vaccine candidate utilizes an adeno-associated virus (AAV) vector to deliver genes encoding HIV proteins and is designed to stimulate an immune response against HIV. Modest immune responses were shown in some recipients who received higher doses of rgAAC09.
In this double-blind, randomized, placebo-controlled study, 91 healthy HIV-negative volunteers at five clinical sites in Africa have received two intra-muscular injections of placebo or tgAAC09 at three different dosage levels either six or 12 months apart. The reported safety data reflect results following the first vaccination and re-vaccination in 91 and 82 volunteers, respectively. To date, the vaccine has been well tolerated, and no severe local or systemic reactions to vaccination have been reported.
Targeted Genetics’s future development plans for this program include the evaluation of vaccine candidates containing several additional HIV-1 genes, either alone or in a prime-boost strategy.