PCPP-Formulated H5N1 Influenza Vaccine Displays Improved Stability and Dose-Sparing Effect in Lethal Challenge Studies |
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Authors: | Alexander K Andrianov Daniel P Decollibus Alexander Marin Ashley Webb Yolanda Griffin Richard J Webby |
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Institution: | 1. Apogee Technology, Inc., Norwood, Massachusetts 02062;2. Department of Infectious Diseases, St. Jude Children''s Research Hospital, Memphis, Tennessee 38105 |
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Abstract: | The potential impact of an influenza pandemic can be mitigated through the realization of a successful vaccination program. The implementation of antigen stabilization and dose-sparing technologies is an important step in improving availability of vaccines at the time of a pandemic outbreak. We investigated polydi(carboxylatophenoxy)phosphazene] (PCPP) as a potential stabilizing and immunostimulating agent for H5N1 influenza vaccine. Physicochemical characterization of PCPP-formulated H5N1 influenza vaccine revealed macromolecular complexation in the system, whereas single radial immunodiffusion assay verified antigenicity of the formulation in vitro. PCPP-enhanced formulation displayed a fourfold increase in the half-life at 40°C compared with a nonadjuvanted vaccine. Lethal challenge studies in ferrets demonstrated 100% protection for low-antigen dose PCPP-adjuvanted formulations (1 μg of hemagglutinin) and at least a 10-fold antigen-sparing effect. Therefore, PCPP demonstrated an ability to improve thermal stability of H5N1 influenza vaccine in solutions and provide for a substantial dose-sparing effect in vivo. |
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