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Inovio Pharmaceuticals, Inc. Message Board

  • rehdvm2004 rehdvm2004 Oct 10, 2013 8:52 AM Flag

    FDA Guidance for Industry - Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (excerpted) . . .

    Longs should know that mice are the standard animal model for developing and proving vaccines are effective.

    "V. PRECLINICAL IMMUNOGENICITY AND SAFETY" (Before any clinical trial is proposed to the FDA or EMEA, the vaccine must vaccinate and cause an antibody response)
    "B. Immunogenicity
    We recommend that vaccine immunogenicity be assessed in a relevant animal model whenever possible. This may include the evaluation of antigen-specific antibody titers, seroconversion rates, activation of cytokine secreting cells, and/or measures of cell-mediated immune responses. Unless they are also safety studies, pre-clinical immunogencity studies are not subject to the GLP regulations, which do not apply to basic exploratory studies carried out to determine whether a test article has potential utility (21 CFR 58.3(d)). For DNA vaccines that encode multiple antigens, you should assess the immune response generated against a representative subset of the encoded antigens."

    F. Local Reactogenicity and Systemic Toxicity Studies" (The vaccine cannot cause a damaging or disfiguring reaction at the site of injection)
    "For studies of injection site reactogenicity, you should include detailed clinical observations of the injection site(s) following each vaccine administration and histological evaluations of injection-site tissue obtained from biopsies or term necropsy samples. You should evaluate both short-term and persistent toxicity, preferably by studying separate cohorts of animals 2 to 3 days and 2 to 3 weeks after the final vaccination."

    Additionally, whatever animal model was used to show this type of response preclinically has to be used on a vaccine batch-by-batch basis as a release test.

    So the dummy that keeps saying mouse or nonhuman primate studies are relevant to Inovio's progress foreward . . . well let's just say he/she "gives stupid people a bad name." (Quote from Jamie Leigh Curtis to Kevin Klein from "A Fish Called Wanda.")

    GLTAL

    Sentiment: Strong Buy

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