Glaxosmithkline Biologicals Sa

The Brigham and Women's Hospital, Inc.

Pfizer Ireland Pharmaceuticals

Pierre Duvivier

Ralph Leon Biemans

Jan Poolman

Philippe Denoel

Dominique Boutriau

Carine Capiau

Ollivier Francis Nicolas Gavard

Tomas Maira-Litran

Carine Goraj

Ollivier Francis Gavard

Olivier Francis Nicolas Gavard

The present application discloses an immunogenic composition comprisingcapsular polysaccharides from at least one of serogroups A, C, W135 and Y conjugated to a carrier protein to produce acapsular polysaccharide conjugate, wherein the average size of eachpolysaccharide is above 50 kDa.

Immunogenic composition

The present invention relates to a process for conjugation of an antigen.

Conjugation process

The present application discloses an immunogenic composition comprising at least 2 differentcapsular saccharides, wherein one or more is/are selected from a first group consisting of MenA, MenC, MenY and MenW which is/are conjugated through a linker to a carrier protein(s), and one or more different saccharides is/are selected from a second group consisting of MenA, MenC, MenY and MenW which is/are directly conjugated to a carrier protein(s).

present application discloses an immunogenic composition comprisingcapsular polysaccharides from at least one of serogroups A, C, W135 and Y conjugated to a carrier protein to produce acapsular polysaccharide conjugate, wherein the average size of eachpolysaccharide is above 50 kDa.

The present application relates to an immunogenic composition comprising at least 2 conjugates ofcapsular saccharide and protein carrier, wherein said conjugates comprise at least 2 differentcapsular saccharides selected from the group consisting of MenA, MenC, MenY and MenW, wherein at least one capsular saccharide is conjugated to a protein carrier with a saccharide:protein ratio (w/w) between 1:2-1:5, and wherein at least one different capsular saccharide is conjugated to a protein carrier with a saccharide:protein ratio (w/w) between 5:1-1:1.99.

The present application discloses an immunogenic composition comprising at least 2 differentcapsular saccharides, wherein one or more is/are selected from a first group consisting of MenA, MenC, MenY and MenW which is/are conjugated to a protein carrier(s) wherein the saccharide:protein ratio (w/w) is between 1:2-1:5, and one or more different saccharides is/are selected from a second group consisting of MenA, MenC, MenY and MenW which is/are conjugated to a protein carrier(s) wherein the saccharide:protein ratio (w/w) is between 5:1-1:1.99.

The present application discloses an immunogenic composition comprising a Hib saccharide conjugate, at least one additional bacterial, for example, saccharide conjugate(s), and a further antigen selected from the group consisting of whole cell pertussis and hepatitis B surface antigen, wherein the saccharide dose of the Hib saccharide conjugate is less than 5 &#x3bc;g.

Process for conjugation of bacterial saccharides includingandsaccharides by reductive amination are provided herein.

Conjugation process of bacterial polysaccharides to carrier proteins

The present application describes a process for conjugating a PNAG which is less than 40% N-acetylated to a carrier protein.

Conjugation process for PNAG and a carrier protein

The present application discloses an immunogenic composition comprising a Hib saccharide conjugate, at least one additional bacterial, for example, saccharide conjugate(s), and a further antigen selected from the group consisting of whole celland hepatitis B surface antigen, wherein the saccharide dose of the Hib saccharide conjugate is less than 5 &#x3bc;g.

The present application discloses a method for making an immunogenic composition comprising an improved way of conducting saccharide-protein conjugation reactions using carbodiimide condensation chemistry. Depending on the nature of the saccharide or protein carrier involved, the quality of the conjugate may be improved by adding one of the reaction components slowly to the reaction mixture. In addition, the conjugate is mixed with a staphylococcal antigen. Immunogenic compositions are further provided comprising the saccharide-protein conjugates made by the methods disclosed.

Process for manufacturing vaccines

The present application discloses an improved method for conducting saccharide&#x2014;protein conjugation reactions using carbodiimide condensation chemistry. Depending on the nature of the saccharide or protein carrier involved, the quality of the conjugate may be improved by adding one of the reaction components slowly to the reaction mixture. Immunogenic compositions are further provided comprising the saccharide-protein conjugates made by the methods disclosed.

Growing community of inventors

Rixensart, Belgium

Pierre Duvivier