MUCOSAL PLANTIBODIES--A HUMAN ANTIHSV SIGA

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The overall goal is to develop antibody-based technology that can be used in consumer products for the prevention of sexual transmission of diseases (STDs). A small volume gel that provides 24 hours of STD protection could be used much like other consumer-based products that are used once a day or as needed. The well-established potency and specificity of antibodies make them ideal agents for discreet use by women or in combination with lubricants. The specific aims of this proposal are designed to determine the safety, efficacy and acceptability of antibody-based products. The proposed studies will: (a) measure the residence half time of a topically applied antibody in the human vagina; (b) develop the first human SIgA in a low cost, high capacity production system; (c) determine if anti-HSV2 plantibodies are stable in ex vivo secretions and are efficacious in vivo when used alone and when combined with a commercially available vaginal formulation and a sexual lubricant; (d) determine if mice absorb SIgA plantibodies by direct measurement of plantibodies in serum and indirectly by measurement of systemic and mucosal mouse anti-plantibody. PROPOSED COMMERCIAL APPLICATION: Antibody-based technology is now coming to fruition for systemic therapeutics, but an untapped commercial applications for antibodies are in mucosal prevention. Vaginal microbicides is one important application for mucosal antibodies but the technology is so flexible that it is readily extended to the prevention of diseases by pathogens at other mucosal sites.