The long term objectives of the project are to produce an effective human vaccine against avian influenza which can be used in a pandemic. The threat of avian influenza virus to human global health still remains a real one and concerted vaccine development is imperative. Inactivated, egg adapted avian virus (H9N2) will be manufactured according to good manufacturing practices and tested for safety, sterility, and potency using FDA approved protocols. Parkedale Pharmaceuticals, Inc. has experience that dates five decades with influenza vaccine. A chicken egg adapted virus would easily slot into our manufacturing process. Recent, in-house research has demonstrated that liposomal antigen delivery systems can allow the use of reduced influenza vaccine doses in attaining protective serum titers. Clinical use of liposomes with a reduced dose of avian virus antigen should greatly extend the number of individuals who can be effectively immunized. We propose to conduct dose response studies with adjuvant and non-adjuvanted vaccine in our ferret model. Optimal formulations will then be used in clinical trials to establish safety and surrogate markers of efficacy.
