call 2004: post-genomic approaches to a human pandemic influenza vaccine project title: live...
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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
BioTest, CZAnimal Trials
BIA Separations, SIVirus Purification
Medical University Vienna, AT
Robert Koch Institute, DEInfluenza B
AVIRGreen Hills Biotechnology
Coordination + ManagementReverse Genetics
Vaccine ProductionFormulation
GPC-Biotech, DEKinase Inhibitors
Institute of Influenza, RUSClinical Trials
Weikom, ATPublic Relations
SurgeryReverse Genetics
Clin. Pharm.Clinical Trials
VirologyInfluenza
Diagnostics
Vichem, HUKinase Inhibitors
Henogen, BEContract Manufacturer
FluVacc
FluVacc/Flureplication-deficient intranasal influenza vaccine
FLU vaccine viruses are based on deletion of the interferon-antagonist NS1
wild-type NS1
FLU vaccine properties:
• Replication deficient safe• Interferon induction immunogenic
• Randomized, double blind, placebo-controlled • Single immunization, dose escalation• 48 male adult volunteers• Primary objective: safety, tolerability• Secondary objectives: immune response, PK (shedding)
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
Results beyond state of the art