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FluVac


Vaccines and Correlates of Protection

Dose Sparing and Increased Immunogenicity for Vaccination Against Pandemic Influenza with Covaccine HT

EC contribution
: € 3 500 000
Duration
: 48 months
Starting date
: Planned for 01/07/2007
Instrument
: STREP
Keywords
: Adjuvant, vaccine, dose-sparing, efficacy, influenza, pandemic, emergency vaccination
Project Number
: 44407
Web-site
: -

Summary:

The risk of a new influenza pandemic is emphasised by a WHO report documenting several hundreds of recent cases of human infection with a new virus strain and approximately 50% mortality. Control or prevention of a pandemic by emergency vaccination depends on availability of products with high efficacy and broad protection. The combination of an effective adjuvant and cell culture technologies for antigen production meets the requirements of a pandemic influenza vaccine.

The consortium of this FluVac project, among them proven and renowned experts in human vaccine development and influenza research, plans to deliver a prototype vaccine with proof-of-concept within 48 months. Optimal doses of inactivated, cell culture-derived whole influenza virus (H5N1) and CoVaccine HT as adjuvant will be tested in pre-clinical and clinical studies. In comparison to the widely used production system in eggs, production in cell culture offers the advantages of immediate and reliable availability of antigen of constant quality and with reduced risk of contamination.

The use of whole virus in a vaccine instead of subunits, is considered to induce broader protective immunity. The novel adjuvant CoVaccine HT has been shown to elicit high humoral and cellular responses against different types of antigens, including inactivated influenza virus, and in different animal species (mice, rats, rabbits, pigs, horses, primates, etc.). It is considered to be a promising candidate for a pandemic influenza vaccine. A Phase I trial, human challenge study and extensive immunological evaluation of the vaccine prototype will provide the information required for further development and registration (Scheme 1).

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