Multivalent pneumococcal polysaccharide-protein conjugate...

A - Human Necessities – 61 – K

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A61K 39/395 (2006.01) A61K 39/02 (2006.01) A61K 39/09 (2006.01)

Patent

CA 2673558

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. Also described is a method for making an immunogenic conjugate comprising Streptococcus pneumoniae serotype 1 polysaccharide covalently linked to a carrier protein, the method including partial de-O-acetylation of the polysaccharide by mild hydrolysis in an alkaline pH buffer.

Composition immunogène comptant 13 conjugués protéine-polysaccharide 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 and 23F) conjugué à une protéine porteuse. Formulée en tant que vaccin, la composition immunogène permet d'augmenter globalement la couverture contre les maladies pneumococciques chez les nourrissons et les jeunes enfants et fournit pour les sérotypes 6A et 19A une couverture non dépendante des limitations de la protection croisée des sérogroupes. L'invention concerne également une méthode de fabrication d'un conjugué immunogène comprenant un polysaccharide du sérotype 1 de Streptococcus pneumoniae relié à une protéine porteuse, avec O-acétylation partielle du polysaccharide par hydrolyse douce dans un tampon pH alcalin.

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