METHOD OF PRODUCING MENINGOCOCCAL MENINGITIS VACCINE FOR NEISSERIA MENINGITIDIS SERO TYPES A,C,Y, and W-135

Abstract

Methods for producing quadrivalent meningococcal meningitis polysaccharide and conjugate vaccines for serotypes A, C, Y and W-135 disclosed. Neisseria meningitidis fastidious medium was designed to maximize the yield of capsular polysaccharides and generate minimal cellular biomass and endotoxin in a short duration of fermentation. The crude polysaccharides are isolated, purified, and mechanically depolymerized by sonication. These purified polysaccharides were found in human clinical trials to be safe and immunogenic against meningococcal disease caused by N. meningitidis A, C, Y and W-135 serogroups in sub-Saharan Africa. In the preferred embodiment, the polysaccharides are conjugated to carrier proteins of diphtheria or tetanus toxiod to an average molecular size of 5100 to 9900 Daltons and provide broad spectrum protection to humans of all ages. Accelerated polysaccharide production and the efficacy of the resulting vaccine are demonstrated.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is based on provisional application U.S. Ser. No. 60 / 831,682 filed on Jul. 19, 2006.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates generally to the field of medical microbiology, immunology, vaccines and the prevention of infection by a bacterial pathogen by immunization.[0004]2. Description of the Related Art[0005]Meningococcal meningitis is an infection of the meninges, the thin lining that surrounds the brain and the spinal cord. The causative agent, Neisseria meningitidis (the meningococcus), was identified in 1887. Meningococcal disease was first reported in 1805 when an outbreak swept through Geneva, Switzerland.[0006]Twelve subtypes or serogroups of N. meningitidis have been identified and four (N. meningitidis. A, B, C and W-135) are known to cause epidemics. The pathogenicity, immunogenicity, and epidemic capabilities differ according to the serogroup. Thus the ident...

AI Technical Summary

Benefits of technology

[0050]Methods for producing quadrivalent meningococcal meningitis polysaccharide vaccine for serotypes A, C, Y and W-135 by mechanical means: The methods employ Neisseria meningitidis fastidious medium specially designed to maximize the yield of capsular polysaccharides and minimize yield of the cellular biomass and endotoxins. The crude polysaccharides are isolated and purified by ultra-filtration and gently treated with a polycationic compound that precipitates the polyanionic capsular polysaccharides a

Problems solved by technology

Bacterial meningitis may result in brain damage, hearing loss, or learning disability in 10 to 20% of survivors.

During the dry season, between December and June, because of dust winds and upper respiratory tract infections due to cold nights, the local immunity is diminished, increasing the risk of meningitis.

Polysaccharides themselves are poor at stimulating an effective antibody response in the highest risk age groups (infants).

The problem with the invention disclosed in this patent is that the phenol contaminants may interfere with the pure polysaccharide production process.

The problem with the invention disclosed in this patent is that the phenol contaminants may interfere with the pure polysaccharide production pr

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