RECOMBINANT PROTEINS THAT CAN BE EXPRESSED IN ESCHERICHIA COLI AS ACTIVE INGREDIENTS OF VACCINES AGAINST 2009 OUTBREAK H1N1 INFLUENZA A, AND PRODUCTION METHOD THEREOF

摘要

The present invention relates to a group of recombinant proteins (generally referred to in the present document as HA_50-274-H1N1) which can be expressed in E. coli, which contain a hemagglutinin (HA) fragment of the H1N1/2009 influenza A virus in the sequence thereof and which exhibit immunogenic and protective activity against influenza infection in mammals. This fragment corresponds to the region between amino acid 50 and amino acid 274 of H1N1/2009 influenza A virus hemagglutinin (SEQ ID No. 1). The invention also relates to a plurality of clones capable of expressing said group of immunogenic and protective proteins, for example clones such as E. coli BL21 (DE3) pLysS C41 deposited at the ATCC^® under patent deposit designation PTA-10320. The invention further relates to the use of said proteins as vaccines or ingredients in formulations for vaccines against H1N1/2009 influenza A infection or seasonal influenza infection. In addition, the invention relates to a method whereby HA_50-274-H1N1 protein variants can be produced with a suitable level of biological activity (specific recognition of human serum antibodies in patients convalescing from H1N1/2009 influenza A, specific immunogenic activity in mammals, protective activity in mammalian cell cultures and animal models) and a sufficient level of purity for industrial use.