Immunogenicity and protective efficacy of intranasal delNS1(H5N1) influenza vaccine

Project Information

INTRANASAL H5VACCINE

Grant agreement ID: 44512

Project closed

Start date 1 January 2007

End date 30 June 2010

Funded under

• Policy support: Specific activities covering wider field of research under the Focusing and Integrating Community Research programme 2002-2006.

Total cost € 3 865 880,00

EU contribution € 2 680 400,00

Coordinated by

AVIR GREEN HILLS BIOTECHNOLOGY RESEARCH DEVELOPMENT TRADE AG
Austria

Objective

The aim of the project is to characterize replication-deficient pandemic influenza vaccine candidates (H5N1) in clinical and preclinical studies. The replication-deficient vaccine is based on the deletion of the NS1 protein (DelNS1 vaccine).
First, several vaccine candidates will be screened for parameters including antigenic properties, receptor specificity, attenuation and immunogenicity in animal models. Studies on elucidation of mechanisms responsible for protection will comprise parameters of innate an d adaptive immunity.
Several standardized immunological techniques such as hemagglutination inhibition (HI) and ELISA will be used for evaluation of vaccine candidates. In addition, novel sensitive methods based on synthetic sialic receptor analogues will be developed for assessment of the antibody response against the hemagglutinin (HA) and neuraminidase (NA). Protective properties of the vaccine against homologous and heterologous influenza strains will be tested in ferret challenge experiments using dif ferent H5 strains. To close the gap between the ferret model and human studies we will use the macaque model to evaluate the immune response.
These pre-clinical studies will allow the selection of the most potent vaccine candidate, which will be produced according to cGMP guidelines on Vero cells. After toxicological evaluation of the vaccine, clinical phase I/II studies will be performed. If permitted by authorities, a human challenge study using attenuated H5 virus will be carried out. Alternatively, for proof of principle of the delNS technology, an H1-delNS1 vaccine will be produced and used in an H1 challenge study.

Fields of science

• natural sciences › biological sciences › microbiology › virology
• natural sciences › biological sciences › biochemistry › biomolecules › proteins
• medical and health sciences › health sciences › infectious diseases › RNA viruses › influenza
• medical and health sciences › basic medicine › immunology
• medical and health sciences › basic medicine › pharmacology and pharmacy › pharmaceutical drugs › vaccines

Keywords

• challenge study
• clinical trial
• intranasal
• pandemic influenza
• replication deficient
• reverse genetics
• vaccine

Programme(s)

• FP6-POLICIES - Policy support: Specific activities covering wider field of research under the Focusing and Integrating Community Research programme 2002-2006.

Topic(s)

• POLICIES-2.2 - Public health issues, including epidemiology contributing to disease prevention and responses to emerging rare and communicable diseases, allergies, procedures for secure blood and organ donations, non-animal test methods

Call for proposal

FP6-2005-SSP-5-B-INFLUENZA
See other projects for this call

Funding Scheme

STREP - Specific Targeted Research Project

Coordinator

AVIR GREEN HILLS BIOTECHNOLOGY RESEARCH DEVELOPMENT TRADE AG

• EU contribution: No data
• Address: Gersthofer Strasse 29-31 ; VIENNA ; Austria
• Total cost: No data

Participants (5)

BIOTEST S.R.O.

Czechia

• EU contribution: No data
• Address: Pod Zamken 279 ; KONAROVICE
• Total cost: No data

SHEMYAKIN & OVCHINNIKOV INSTITUTE OF BIOORGANIC CHEMISTRY RUSSIAN ACADEMY OF SCIENCE

Russia

• EU contribution: No data
• Address: Miklukho-Maklaya 16/10 ; MOSCOW
• Total cost: No data

RETROSCREEN VIROLOGY LTD.

United Kingdom

• EU contribution: No data
• Address: 327 Mile End Road ; LONDON
• Total cost: No data

KLINIKUM DER JOHANN WOLFGANG GOETHE-UNIVERSITÄT

Germany

• EU contribution: No data
• Address: Theodor Stern Kai 7 ; FRANKFURT AM MAIN
• Total cost: No data

MEDIZINISCHE UNIVERSITÄT WIEN

Austria

• EU contribution: No data
• Address: Spitalgasse 23 ; VIENNA
• Total cost: No data