Multivalent meningococcal polysaccharide-protein conjugate vaccine

摘要

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.

主权项

1. An immunological composition comprising a mixture of four distinct and separately made protein-capsular polysaccharide conjugates, wherein the first conjugate comprises purified Neisseria meningitides capsular polysaccharide of serogroup W-135 conjugated to a purified carrier protein, the second conjugate comprises purified N. meningitidis capsular polysaccharide of serogroup Y conjugated to a purified carrier protein, the third conjugate comprises purified N. meningitidis capsular polysaccharide of serogroup A conjugated to a purified carrier protein, and the fourth conjugate comprises purified N. meningitidis capsular polysaccharide of serogroup C conjugated to a purified carrier protein, wherein each of the N. meningitidis serogroups A, C, W-135 and Y capsular polysaccharides is derivatized with adipic acid dihydrazide, and wherein the immunological composition is 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 the N. meningitidis serogroups A, C, W-135 and Y capsular polysaccharides, wherein said serum bactericidal antibody response is higher than that elicited by the licensed, unconjugated, tetravalent A, C, W-135 and Y meningococcal capsular polysaccharide vaccine, and further wherein the immunological composition is capable of eliciting a booster anamnestic IgG response to each of the N. meningitidis serogroups A, C, W-135 and Y capsular polysaccharides.