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Opal-HIV-Gag(c) is a DNA vaccine candidate designed for the prevention and treatment of HIV-1 infection, specifically targeting the subtype C variant prevalent in Southern Africa. Developed by FIT Biotech using their proprietary Gene Transport Unit (GTU) technology, the vaccine consists of a plasmid DNA vector that encodes a consensus sequence of the HIV-1 Gag polyprotein, along with other regulatory and non-structural proteins including Rev, Nef, Tat, and a modified reverse transcriptase. The GTU platform is engineered to enhance the expression and stability of these antigens within host cells, thereby eliciting a broad and robust T-cell mediated immune response, particularly CD8+ cytotoxic T-lymphocyte activity. Clinical evaluation has focused on its safety and immunogenicity in both healthy volunteers and HIV-infected individuals, often as part of prime-boost regimens.
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