Intranasal Pandemic Influenza Vaccine
A highly pathogenic form of avian influenza virus (H5 subtype) is panzootic in poultry, can transmit from poultry to humans and has the potential to cause another global influenza pandemic. This project is a response to the need to develop an effective, user friendly, thermally stable influenza vaccine.
The overall objective of this programme is to develop a nasal avian influenza vaccine using ChiSys (chitosan), which is an enabling chitosan-based vaccine-delivery technology of Archimedes Development Ltd. Chitosan has already been tested with several nasally delivered antigens in pre-clinical models and in the clinic, with excellent results. The most effective way of controlling a pandemic flu would be by vaccination via the nasal route. The nasal route has the advantage of generating both systemic and mucosal immunity; the latter allowing control of the virus at its point of entry. In contrast, the currently used injectable vaccine does not generate mucosal immune response. Intranasal vaccination also has the advantages of 1) avoiding the need for injection, thereby not requiring disposal of syringes and eliminating the risk of HIV transmission through re-use or accidental contact with body fluids, 2) having greater public compliance and 3) being well-suited to rapid mass global vaccination programmes.
This project will evaluate efficacy and toxicity in pre-clinical studies and will evaluate efficacy and safety in humans, with the scientific objective of inducing both systemic and mucosal immunity, while providing a substantial level of cross-immunity against drifted strains of H5 or H7. The approach will be effective at low dose to meet the global demands from limited vaccine stockpiles, will have thermal stability to avoid the requirement for refrigerated storage and transportation and will employ a user friendly vaccine applicator.
The extensive experience of all members of the consortium in their specialist fields, including basic immunology, development, vaccine trials and the virology and immunology of influenza virus provides the optimum circumstances for success of this project. ChiSys is an excellent candidate delivery system for developing an intranasal pandemic influenza vaccine to provide a quantum leap in successfully combating pandemic influenza globally.[+] Read More
The highly pathogenic form of avian influenza virus (H5N1) has the potential to cause another global influenza pandemic. A major problem confronting pandemic planners is ensuring adequate global vaccine supplies. Manufacturing capacity for influenza vaccines is limited and clinical trials to date with non-adjuvanted split-product or subunit inactivated vaccines have found these to be poorly immunogenic needing increased dosages of antigen content. Furthermore avian influenza strains are continuously drifting antigenically. Therefore dose-sparing strategies and development of a vaccine providing long-lasting, cross-subtype protection is required.
Develop a nasal avian influenza vaccine, which induces durable, broad, mucosal and systemic immune responses, is easily administered by needle-free delivery using technology that could be used for any potential antigen, is thermally stable and cost effective.
With a successful outcome of this project, further clinical data will then generate a robust data package which demonstrates that the intranasal vaccine provides safe and effective immunisation against avian influenza. These data will be suitable for regulatory filing in order to obtain product licence, scale up manufacture and commercialise a nasal vaccine for pandemic influenza.