The problem

Better anti-influenza vaccines are being urgently sought to counter the increasing risk of a major pandemic, due to the transmission of avian influenza (‘bird flu’) to humans and related threats. Intranasal administration is likely to be the most effective route to deliver a vaccine against serious upper respiratory tract infections, but no acceptable intranasal influenza vaccine is currently available. An easily used intranasal vaccine is also preferable to injected alternatives because it maximises acceptance of the vaccine among populations at risk.

Overview:

IntranasalH5Vaccine will develop and test an intranasally administered H5N1 influenza vaccine based on viruses that have been made ‘replication deficient’ by the removal of key genes from the viral genome.

The project will:

• Develop new vaccine candidates from existing whole virus vaccines, using genetic modification
• Develop new immunological tests for evaluating vaccine effectiveness
• Test vaccine candidates for safety and efficacy in animal trials
• Use clinical trials to select and study the most potent vaccine candidate

Contribution to policy development:

• IntranasalH5Vaccine will help EU policy to prepare for the risk of influenza pandemics.
• It will foster the competitiveness of EU vaccine research.
• The project will strengthen the role of European companies in global vaccine supply.

Project deliverables

• Development of six vaccine candidates – June 2007
• Set of validated tests for immunological studies – December 2008
• Results of animal trials – January 2009
• Results of clinical trials – December 2009
• Final selected vaccine released for further clinical evaluation – December 2009

Dissemination

• Direct contacts with pharmaceutical companies that are potential distributors of the vaccine – from January 2007
• Newsletter to inform selected stakeholders about progress of the project – at regular intervals
• Publication of results in scientific journals – as appropriate
• Website carrying non-confidential information for release to the general public – from 2007

Technical information

Project acronym: IntranasalH5vaccine
Project’s official full title: Immunogenicity and protective efficacy of intranasal delNS1(H5N1) influenza vaccine
Research priority: Health determinants and the provision of high quality and sustainable health care services and pension systems (in particular in the context of ageing and demographic change)
Specific webpage: www.greenhillsbiotech.com/EU_project.html
Proposal/contract no: 044512
Start date: January 2007
Kick off meeting: January 2007
Completion date: December 2009
European Commission scientific officer: Cornelius Schmaltz, Cornelius.SCHMALTZ@ec.europa.eu  

Coordinator:
Name: AVIR Green Hills Biotechnology
Abbreviated name: GHB
Address: Gersthofer Str. 29-31, A-1180 Wien
Country: Austria
Tel: +43 (0) 1 31 99 670
Fax: +43 (0) 1 31 96 099
Website: http://www.greenhillsbiotech.com

Partners

Name: Biotest s.r.o
Abbreviated name: BT
Country: Czech Republic

Name: Medical University of Vienna
Abbreviated name: MUV
Country: Austria

Name: Klinikum der J. W. Goethe-Universität Frankfurt/Main
Abbreviated name: GUF
Country: Germany

Name: Shemyakin Institute of Bioorganic Chemistry
Abbreviated name: IBC
Country: Russia

Name: Retroscreen Virology Ltd
Abbreviated name: RS
Country: United Kingdom