The problem

The recent epidemic of a new pathogenic strain of H5N1 influenza in birds in Asia has fuelled further concerns about a potential influenza pandemic. In such an event, large quantities of a highly effective vaccine will be needed at short notice. The project consortium will collaborate on the development of such a vaccine, taking advantage of complementary expertise and technology within the consortium.

Overview:

The FluVac project will provide proof-of-concept testing for safety, effectiveness, and potency of a CoVaccine HT-adjuvanted pandemic whole virus influenza vaccine in humans. The project will be founded on the use of a non-pathogenic H5N1 mutant strain provided by WHO. Ambitious clinical immunology plans address all known aspects of protective immunity against influenza. The standard influenza serology (HI antibody titre) will be complemented with virus neutralisation tests and analyses of both helper and cytotoxic T-cell responses. FluVac will determine the minimal effective dose and select a vaccine composition for human challenge studies to be performed under strictly controlled conditions with a suitable challenge strain (to be defined in preclinical studies and according to consensus recommendations of experts of the influenza field).

Contribution to policy development:

• Identification and preparation of effective novel influenza vaccines will help prepare the EU for fighting a pandemic
• Work undertaken and knowledge gained in the course of this project will enable the EU to take a leading role in fighting any inter-continental outbreak of influenza
• The project will help develop new systems for rapid preparation of treatments, build international partnerships and strengthen European commercial competitiveness

Project deliverables

• Knowledge of the immunogenicity and protective efficacy of candidate vaccines – Aug 2008
• Safety and capacity of CoVaccine HT to enhance neonatal and elderly CD4⁺ and CD8⁺ T cell responses to the pandemic H5N1 influenza vaccine – Oct 2008
• Preliminary results with table and lists of geometric mean titres (GMT) for prototype vaccine – Sept 2009
• Potential advantage of intranasal immunisation of neonatal mice with prototype vaccine – June 2010
• CTL responses induced by the candidate vaccine – June 2010, 2011
• The capacity of CoVaccine HT to enhance neonatal B cell responses to the pandemic H5N1 influenza vaccine (CR3, CR1) – Final report – June 2011

Dissemination

• The consortium will promote the exchange of knowledge and ideas through formal and informal networks, thereby opening new opportunities for innovative research directed to applied influenza products.
• The scientific results will be published in peer-review journals, at conferences and other appropriate meetings
• External groups including the international press and media, pharmaceutical industry, partners and competitors and the financial community will be kept informed of progress

Technical information

Project acronym: FluVac
Project’s official full title: Dose sparing and increased immunogenicity of pandemic influenza vaccine by CoVaccine HT
Specific webpage: Details not yet available
Proposal/contract no: 044407
Start date: July 2007
Kick off meeting: July 2007
Completion date: June 2011
European Commission scientific officer: Cornelius Schmaltz

Coordinator:Luuk A.T. Hilgers
Name: Nobilin International BV
Abbreviated name: NOB
Address: P.O. Box 320, Exportstraat 39b, 5830 AH Boxmeer
Country: The Netherlands
Tel: +31 485 58 54 54
Fax: +31 485 58 54 45
e-mail: Luuk.Hilgers@nobilonvaccines.com
Website: www.nobilon.com

Partners

Name: Protherics plc
Abbreviated name: PTI
Country: United Kingdom         

Name: Landspitali University Hospital
Abbreviated name: LUH
Country: Iceland

Name: Retroscreen
Abbreviated name: RS
Country: United Kingdom         

Name: Erasmus Universitair Medisch Centrum Rotterdam
Abbreviated name: EMC
Country: The Netherlands