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HIV gp160 + BCG vaccine (formally named HIV-1 gp160 Protein plus BCG Vaccine) is an investigational therapeutic biologic mixture intended for percutaneous administration in HIV-positive patients without AIDS symptoms. Developed by sponsor-investigator Han Xu, M.D., Ph.D., FAPCR, at Medicine Invention Design Incorporation, the therapy is a combination of two FDA-approved biological products: recombinant HIV-1 gp160 protein and the live-attenuated BCG vaccine (Bacillus Calmette-Guérin, Tice strain). The mixture is administered percutaneously using a multiple puncture device. Its mechanism of action involves activating trained immunity and antigen presentation; the BCG component acts as an immunostimulatory agent that activates antigen-presenting cells (APCs) to process and present the HIV-1 gp160 envelope protein to memory T cells, potentially enabling the immune system to recognize and clear multiple mutated strains of HIV-1. The combination is being evaluated in an early Phase 1 proof-of-concept clinical pharmacology trial (NCT07182838).
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