Multivalent meningococcal polysaccharide-protein conjugate vaccine
AssigneeSanofi Pasteur Limited
InventorRobert P. Ryall
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Abstract
The present invention describes a combined vaccine that offers broad protection against meningococcal disease caused by the pathogenic bacteria Neisseria meningitidis. The vaccine is comprised of four distinct polysaccharide-protein conjugates that are formulated as a single dose of vaccine. Purified capsular polysaccharides from Neisseria meningitidis serogroups A, C, W-135, and Y are chemically activated and selectively attached to a carrier protein by means of a covalent chemical bond, forming polysaccharide-protein conjugates capable of eliciting long-lasting immunity to a variety of N. meningitidis strains in children as well as adults.
Claims23
A method of manufacturing an immunological composition capable of eliciting in children less than two years of age, a primary serum IgG response and a serum bactericidal antibody response to each of Neisseria meningitidis serogroups A, C, W-135 and Y capsular polysaccharides and capable of eliciting a booster anamnestic IgG response to each of the N. meningitidis serogroups A, C, W-135 and Y capsular polysaccharides, the method comprising the steps of:
- (a) purifying capsular polysaccharides from each of the N. meningitidis serogroups A, C, W-135 and Y;
- (b) conjugating each of the purified capsular polysaccharides of step (a) to a purified carrier protein in a separate reaction, wherein four distinct and separately made carrier protein-capsular polysaccharide conjugates are made:
- (c) mixing the four distinct and separately made carrier protein-capsular polysaccharide conjugates of step (b);
- (d) purifying the admixture of the four distinct and separately made carrier protein-capsular polysaccharide conjugates,
- wherein the carrier protein is selected from the group consisting of diphtheria toxoid, CRM197 and tetanus toxoid, and further wherein, the serum bactericidal antibody response in children less than two years of age is higher than that elicited by the licensed, unconjugated, tetravalent A, C, W-135 and Y meningococcal capsular polysaccharide vaccine.
A method of manufacturing a conjugate vaccine capable of eliciting in children less than two years of age, a primary serum IgG response and a serum bactericidal antibody response to each of Neisseria meningitidis serogroups A, C, W-135 and Y capsular polysaccharides and capable of eliciting a booster anamnestic IgG response to each of the N. meningitidis serogroups A, C, W-135 and Y capsular polysaccharides, the method comprising the steps of:
- (a) purifying capsular polysaccharides from each of the N. meningitidis serogroups A, C, W-135 and Y;
- (b) conjugating each of the purified capsular polysaccharides of step (a) to a purified carrier protein in a separate reaction, wherein four distinct and separately made carrier protein-capsular polysaccharide conjugates are made:
- (c) mixing the four distinct and separately made carrier protein-capsular polysaccharide conjugates of step (b);
- (d) purifying the admixture of the four distinct and separately made carrier protein-capsular polysaccharide conjugates,
- wherein the carrier protein is selected from the group consisting of diphtheria toxoid, CRM197 and tetanus toxoid, and further wherein, the serum bactericidal antibody response in children less than two years of age is higher than that elicited by the licensed, unconjugated, tetravalent A, C, W-135 and Y meningococcal capsular polysaccharide vaccine.
Dependencies are inferred from the claim text.