Method for obtaining a vaccine with wide protective range...

A - Human Necessities – 61 – K

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A61K 39/095 (2006.01) A61K 39/00 (2006.01) A61K 39/395 (2006.01) A61K 47/48 (2006.01) C07K 14/22 (2006.01) C07K 14/52 (2006.01) C07K 16/12 (2006.01) C12N 9/00 (2006.01)

Patent

CA 1341199

A method is provided for obtaining a vaccine against the different pathogenic serotypes of group B Neisseria meningitidis characterized by starting from live microorganisms of any one of the known pathogenic serotypes of the B group without inactivation, from which the extractation of the vesicles of the outer membrane and the protein antigenic complex of 65 - 95 KD molecular weight is carried out using detergent, enzyme and ultrasound combined in the treatment. The resulting product, after treatment to eliminate the nucleic acids, is purified by a dissociating treatment with detergent, ultrasonic bath and column chromatography. The multi-antigenic material so obtained is purified to obtain the protein antigenic complex of 65-95 KD molecular weight for further purification by HPLC chromatography (TSK 3000 SWG column) or affinity chromatography with monoclonal antibodies, or hydrophobicity chromatography, or ionic exchange chromatography or a combination of any two or more of them. The protein antigenic complex is then added to a solution that contains vesicles in a proportion of 15 percent ~ 3. The protein antigenic complex is then anchored to the vesicles by ultrasound treatment. The capsular polysaccharide is also added, in a proportion of 1.1 - 1.4 with respect to the protein and the adjuvant in a relation ranging from 20 - 100 mcg/protein mcg. The different components of the mixture may be sterilized by cobalt 60 ionizing radiations with doses from 5 - 25 Kgy and a temperature between 1 - 4°C before preparing the mixture or the resulting mixture may be sterilized by this procedure.

573538

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