Call 2004: Post-genomic approaches to a human pandemic influenza vaccine Project title: Live attenuated replication-defective influenza vaccine, FLUVACC Grant: EUR 9.2 Mio. Program Start: Sept. 2005 BioTest, CZ Animal Trials BIA Separations, SI Virus Purification Medical University Vienna, AT Robert Koch Institute, DE Influenza B AVIR Green Hills Biotechnology Coordination + Management Reverse Genetics Vaccine Production Formulation GPC-Biotech, DE Kinase Inhibitors Institute of Influenza, RUS Clinical Trials Weikom, AT Public Relations Surgery Reverse Genetics Clin. Pharm. Clinical Trials Virology Influenza Diagnostics Vichem, HU Kinase Inhibitors Henogen, BE Contract Manufacturer FluVacc
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Call 2004: Post-genomic approaches to a human pandemic influenza vaccine Project title: Live attenuated replication-defective influenza vaccine, FLUVACC.
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Call 2004: Post-genomic approaches to a human pandemic influenza vaccine Project title: Live attenuated replication-defective influenza vaccine, FLUVACCGrant: EUR 9.2 Mio. Program Start: Sept. 2005
Results: • no significant difference in adverse events compared to placebo• no shedding of vaccine virus• statistical significant immune response compared to placebo (p<0.001)• vaccine induces cross-reactive neutralizing antibodies against drift variants
Clinical trialPhase I seasonal FLU
FLU vaccine is safe and immunogenic in humans
• High immunogenicity strains generated
• Replication-defective phenotype in humans confirmed
• Effective intranasal delivery by spray device achieved
• Reverse genetics method developed
• Production in Vero cells established
• Method to increase viral yield developed
• Efficient and fast purification procedure developed
• Preliminary data clinical trial with pandemic FLU superior