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Development of a combined Influenza/SARS vaccine

Final Report Summary - SARS/FLU VACCINE (Development of a combined Influenza/SARS vaccine)

In 2002, an atypical pneumonia, characterised by progressive respiratory failure, emerged in southern China. The causative agent was rapidly identified as a new coronavirus - designated as Severe acute respiratory syndrome-associated virus SARS-CoV. The disease swept rapidly to neighbouring regions and led to several international cases, including Canada. By the end of the epidemic, in July 2003, about 8 000 SARS cases and almost 800 deaths due to SARS were recorded worldwide.

Avir Green Hills Biotechnology's strategy was based on a chimeric vaccine approach using a replication deficient influenza virus that was modified to express foreign epitopes. The approach is based on the deletion of the interferon antagonist NS1. Several aspects of vaccine development have been addressed by a consortium within the scope of a three and a half years STREP project. The SARS/FLU consortium comprised of industrial and academic partners from Austria, Germany, Slovenia and the Czech Republic.

SARS/FLU focused on the development of a chimeric vaccine based on the Avir Green Hills Biotechnology's replication deficient influenza virus which was developed for use as a safe vector for foreign antigens. By using a delNS1 vector system, a significant immune response is expected, as these vectors induce a strong interferon response.

The objective to generate a replication defective vector for expression of foreign antigens was approached by introducing several model antigens in different sites of the vector virus. Several model epitopes such as antigens from influenza, tuberculosis, melanoma, but also cytokines such as interleukin 2 and interleukin 15 were used to provide a proof of concept. Apart from efficiency data regarding epitope expression genetic stability data was collected.

Regarding SARS, bioinformatics SARS-specific antigens prediction was performed by Emergentec GmbH (Austria) with a proprietary software suite EpiScore. Subsequently, in vitro immunogenicity studies were performed at the Clinics of J. W. Goethe University (Germany) in order to confirm the immunogenicity potential of B- and T-cell epitopes. Selected epitopes were expressed in bacteria and multimers of optimised epitopes were generated. Immunogenicity data in animal studies were performed by BioTest Ltd. (Czech Republic).

In summary, several promising vector candidates were generated and substantial information regarding safety, stability and efficiency of epitope expression was generated. In parallel, the production and purification process for delNS1 based vaccines was developed together with Biaseparations d.o.o. (Slovenia) in small scale.

The output of this cooperative R&D project will be further pursued by the involved partners. Based on positive preclinical results the initiation of the clinical trials of this vaccine approach is planned.