Multivalent pneumococcal polysaccharide-protein conjugate...

A - Human Necessities – 61 – K

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A61K 47/48 (2006.01) A61K 39/085 (2006.01) A61P 31/04 (2006.01)

Patent

CA 2673543

An immunogenic composition having 13 distinct polysaccharide-protein conjugates and optionally, an aluminum-based adjuvant, is described. Each conjugate contains a capsular polysaccharide prepared from a different serotype of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) conjugated to a carrier protein. The immunogenic composition, formulated as a vaccine, increases coverage against pneumococcal disease in infants and young children globally, and provides coverage for serotypes 6A and 19A that is not dependent on the limitations of serogroup cross-protection. Methods for making an immunogenic conjugate comprising Streptococcus pneumoniae serotype 19A polysaccharide are also provided in which the serotype 19A polysaccharide is co- lyophilized with a carrier protein and conjugation is carried out in dimethyl sulfoxide (DMSO) via a reductive amination mechanism.

L'invention concerne une composition immunogène comptant 13 conjugués polysaccaride-protéine distincts et, éventuellement, un adjuvant à base d'aluminium. Chaque conjugué contient un polysaccharide capsulaire obtenu à partir d'un sérotype différent de Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F et 23F) conjugué à une protéine porteuse. Formulée sous forme de vaccin, cette composition capsulaire accroît la protection contre l'infection pneumococcique chez les nourrissons et les jeunes enfants et assure globalement une protection les sérotypes 6A et 19A indépendamment des limitations de la protection croisée du sérogroupe. Sont également décrites des méthodes d'obtention d'un conjugué immunogène comprenant un polysaccharide obtenu à partir du sérotype 19A de Streptococcus pneumoniae dans lequel le polysaccharide de sérotype 19A est co-lyophilisé avec une protéine porteuse et où la conjugaison se fait par l'intermédiaire d'un sulfoxyde de diméthyle (DMSO) via un mécanisme d'amination réductrice..

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