Method of producing Neisseria meningitidis B vaccine, and vaccine produced by method

A vaccine against Neisseria meningitidis B bacteria which is produced by the process comprising the steps performed in the following order:

• a) extracting the vesicles of the outer membrane and protein antigenic complex weighing from 65 to 95 kD from live, active pathogens of group B serotypes with a treatment selected from the group consisting of:
• (i) treating with detergent,
• (ii) treating with detergent and ultrasound, and
• (iii) treating with detergent, enzymatic solution and ultrasound to create an extract;
• b) treating said extract to eliminate nucleic acids to create a treated extract;
• c) purifying said treated extract to separate as a fraction the said vesicles from the protein antigenic complex by a dissociative treatment with detergent solution, ultrasound, and column chromatography to produce purified protein antigenic complex;
• d) further purifying said purified protein antigenic complex by a chromatographic step from the group consisting of high performance liquid chromatography, affinity chromatography with monoclonal antibodies, hydrophobic chromatography, and ionic exchange chromatography, and combinations thereof, to obtain a further purified protein antigenic complex;
• e) combining said further purified protein antigenic complex with a fraction containing the vesicles by ultrasound treatment to anchor said further purified protein antigenic complex and vesicles to each other in an effective amount in s proportion of 15% .+-.3% by weight to create an anchored protein complex;
• and,
• f) adding capsular polysaccharide and adjuvant to anchored protein complex of step (e), wherein the adjuvant is selected from the group consisting of aluminum hydroxide, aluminum phosphate, and calcium phosphate;
• and recovering the resultant vaccine.