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 - PowerPoint PPT Presentation
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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
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Call 2004: Post-genomic approaches to a human pandemic ... Virology. Influenza. Diagnostics. Vichem, HU. Kinase Inhibitors. Henogen, BE. Contract Manufacturer ... – PowerPoint PPT presentation
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Title: 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
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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
FluVacc
Robert Koch Institute, DEInfluenza B
Henogen, BE Contract Manufacturer
BioTest, CZ Animal Trials
Institute of Influenza, RUSClinical Trials
AVIR Green Hills Biotechnology Coordination
Management Reverse GeneticsVaccine
Production Formulation
BIA Separations, SIVirus Purification
Clin. Pharm. Clinical Trials
Medical University Vienna, AT
GPC-Biotech, DE Kinase Inhibitors
SurgeryReverse Genetics
Weikom, ATPublic Relations
Vichem, HU Kinase Inhibitors
VirologyInfluenzaDiagnostics
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FluVacc/DFlu replication-deficient intranasal
influenza vaccine
3
DFLU vaccine viruses are based on deletion of the
interferon-antagonist NS1
wild-type
DNS1
DFLU vaccine properties
- Replication deficient safe
- Interferon induction immunogenic
4
Clinical trial Phase I seasonal DFLU
- 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 (plt0.001) - vaccine induces cross-reactive neutralizing
antibodies against drift variants
DFLU vaccine is safe and immunogenic in humans
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Results beyond state of the art
- 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
DFLU superior
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