Merck Sharp + Dohme Corp.

Jian He

Michael Albert Winters

Chitrananda Abeygunawardana

Luwy Kavuka Musey

Julie Marie Skinner

Yadong Adam Cui

Patrick McHugh

William J Smith

Michael J Kosinski

Emily Wen

Jitin Bajaj

Tanaz Petigara

Romulo Ferrero

John M Williams

Joseph G Joyce

John E MacNair

Hari Pujar

Catherine Lancaster

The invention is related to multivalent immunogenic compositions comprising more than onepolysaccharide protein conjugates, wherein each of the conjugates comprises a polysaccharide from anserotype conjugated to a carrier protein, wherein the serotypes ofare as defined herein. Also provided are methods for inducing a protective immune response in a human patient comprising administering the multivalent immunogenic compositions of the invention to the patient. The multivalent immunogenic compositions are useful for providing protection againstinfection and diseases caused by. The compositions of the invention are also useful as part of treatment regimes that provide complementary protection for patients that have been vaccinated with a multivalent vaccine indicated for the prevention of pneumococcal disease.

Compositions comprisingpolysaccharide-protein conjugates and methods of use thereof

The present invention provides methods for making polysaccharide-protein conjugates in which polysaccharides, typically from bacteria, are conjugated to a carrier protein by reductive amination under conditions which improve conjugation reaction consistency, increase consumption of protein during conjugation reaction, generate conjugates of higher molecular weight, and/or reduce the levels of free cyanide in the conjugate reaction product. The polysaccharide-protein conjugates obtained using these methods are useful for inclusion in multivalent vaccines.

Methods for making polysaccharide-protein conjugates

The invention is related to multivalent immunogenic compositions comprising more than onepolysaccharide protein conjugates, wherein each of the conjugates comprises a polysaccharide from anserotype conjugated to a carrier protein, wherein the serotypes ofare as defined herein. Also provided are methods for inducing a protective immune response in a human patient comprising administering the multivalent immunogenic compositions of the invention to the patient. The multivalent immunogenic compositions are useful for providing protection againstinfection and/or pneumococcal diseases caused by

The invention is related to multivalent immunogenic compositions comprising more than onepolysaccharide protein conjugates, wherein each of the conjugates comprises a polysaccharide from anserotype conjugated to a carrier protein, wherein the serotypes ofare as defined herein. In some embodiments, at least one of the polysaccharide protein conjugates is formed by a conjugation reaction comprising an aprotic solvent. In further embodiments, each of the polysaccharide protein conjugates is formed by a conjugation reaction comprising an aprotic solvent. Also provided are methods for inducing a protective immune response in a human patient comprising administering the multivalent immunogenic compositions of the invention to the patient. The multivalent immunogenic compositions are useful for providing protection againstinfection and diseases caused by. The compositions of the invention are also useful as part of treatment regimes that provide complementary protection for patients that have been vaccinated with a multivalent vaccine indicated for the prevention of pneumococcal disease.

The invention is related to multivalent immunogenic compositions comprising more than onepolysaccharide protein conjugates, wherein each of the conjugates comprises a polysaccharide from anserotype conjugated to a carrier protein, wherein the serotypes ofare as defined herein. In some embodiments, at least one of the polysaccharide protein conjugates is formed by a conjugation reaction comprising an aprotic solvent. In further embodiments, each of the polysaccharide protein conjugates is formed by a conjugation reaction comprising an aprotic solvent. Also provided are methods for inducing a protective immune response in a human patient comprising administering the multivalent immunogenic compositions of the invention to the patient. The multivalent immunogenic compositions are useful for providing protection againstinfection and/or pneumococcal diseases caused by. The compositions of the invention are also useful as part of treatment regimes that provide complementary protection for patients that have been vaccinated with a multivalent vaccine indicated for the prevention of pneumococcal disease.

The present invention provides immunogenic compositions having one or more polysaccharide-protein conjugates in which one or more polysaccharides frombacterial capsules are conjugated to a carrier protein in an aprotic solvent such as dimethylsulfoxide (DMSO). The present invention also provides methods for providing an enhanced immune response to a pneumococcal polysaccharide protein conjugate vaccine comprising administering to a human subject an immunogenic composition comprising polysaccharide-protein conjugates prepared in DMSO conditions.

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Blue Bell, PA, United States of America

Jian He