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A combination investigational product consisting of an HIV-1 gag gene-based plasmid DNA vaccine and the local anesthetic bupivacaine. The vaccine component encodes the full-length or conserved elements of the HIV-1 Gag protein (such as p24CE or p55Gag), designed to elicit cellular immune responses against highly conserved regions of the virus. Bupivacaine is included as a facilitating agent to enhance cellular uptake and stabilization of the plasmid DNA at the injection site. This combination has been evaluated in phase I/II clinical trials for safety, tolerability, and immunogenicity in both people without HIV (as a preventive approach) and people living with well-controlled HIV infection (as an immunotherapeutic strategy). The vaccines are typically administered intramuscularly, sometimes using electroporation for improved delivery[2][3][6]. Developers have included academic groups and companies such as Apollon[1] and Profectus Biosciences[5].
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