Multivalent meningococcal polysaccharide-protein conjugate vaccine
AssigneeSanofi Pasteur Limited
InventorRobert P. Ryall
Life of this patent
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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.
Claims54
A method of vaccinating a human susceptible to infection due to Neisseria meningitidis comprising administering to the human an immunologically effective amount of an immunological composition comprising a mixture of four distinct and separately made protein-capsular polysaccharide conjugates, wherein the first conjugate comprises purified Neisseria meningitidis 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 the immunological composition has the capacity to elicit 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 has the capacity to elicit a booster anamnestic IgG response to each of the N. meningitidis serogroups A, C, W-135and Y capsular polysaccharides.
A method of vaccinating a human susceptible to infection due to Neisseria meningitidis comprising administering to the human an immunologically effective amount of a tetravalent conjugate vaccine comprising a mixture of four distinct and separately made protein-capsular polysaccharide conjugates, wherein the first conjugate comprises purified Neisseria meningitidis 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 the tetravalent conjugate vaccine has the capacity to elicit 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 conjugate vaccine has the capacity to elicit a booster anamnestic IgG response to each of the N. meningitidis serogroups A, C, W-135and Y capsular polysaccharides.
An immunological composition comprising a mixture of four distinct and separately made protein-capsular polysaccharide conjugates, wherein the first conjugate comprises purified Neisseria meningitidis capsular polysaccharide of serogroup W-135conjugated to a purified carrier protein, the second conjugate comprises purified N. meningitidiscapsular 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 the immunological composition has the capacity to elicit 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 has the capacity to elicit a booster anamnestic IgG response to each of the N. meningitidis serogroups A, C, W-135 and Y capsular polysaccharides.
A tetravalent conjugate vaccine comprising a mixture of four distinct and separately made protein-capsular polysaccharide conjugates, wherein the first conjugate comprises purified Neisseria meningitidis capsular polysaccharide of serogroup W-135conjugated to a purified carrier protein, the second conjugate comprises purified N. meningitidiscapsular 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 N. meningitidis capsular polysaccharide of serogroup C conjugated to a purified carrier protein, wherein the tetravalent conjugate vaccine has the capacity to elicit in children less than two years of age a primary serum IgG response and a serum bactericidal antibody response to each of the N. meningitidisserogroups 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-135and Y meningococcal capsular polysaccharide vaccine, and further wherein the conjugate vaccine has the capacity to elicit a booster anamnestic IgG response to each of the N. meningitidis serogroups A, C, W-135 and Y capsular polysaccharides.
Dependencies are inferred from the claim text.