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The HER2 DNA vaccine is an investigational cancer immunotherapy designed to induce an immune response against the human epidermal growth factor receptor 2 (HER2, also known as ERBB2), a transmembrane tyrosine kinase receptor overexpressed in several aggressive cancers, most notably breast cancer. The vaccine consists of plasmid DNA encoding all or part of the HER2 protein. Upon intramuscular injection and uptake by host cells, the encoded antigen is expressed and presented to the immune system, stimulating both humoral (antibody-mediated) and cellular (T cell-mediated) immunity against tumor cells expressing HER2. Preclinical studies have demonstrated that this approach can delay or prevent tumorigenesis in animal models by generating cytotoxic T lymphocyte responses and anti-HER2 antibodies[1][4][6]. Early-phase clinical trials have shown that these vaccines are safe and capable of eliciting anti-tumor immune responses in patients with breast cancer[3][4]. The primary indication under investigation is prevention of recurrence or progression in patients with HER2-positive cancers.
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