Polyanionic polymer adjuvants for haemophilus influenzae b saccharide vaccines
AssigneeGlaxosmithkline Biologicals SA
InventorsNathalie Marie-Josephe GARCON, Dominique LEMOINE, Florence Emilie Jeanne Francoise WAUTERS
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Abstract
The present invention relates to methods of reducing flocculation in an immunogenic composition, where said immunogenic composition comprises (a) Haemophilus influenzae B capsular polysaccharide or oligosaccharide (PRP) and (b) at least one non-PRP antigen. The invention further relates to kits comprising (i) a first composition comprising a Haemophilus influenzae B capsular polysaccharide or oligosaccharide (PRP) and a polyanionic polymer, and (ii) a second composition comprising a non-PRP antigen adsorbed onto an adjuvant with a zero point charge greater than 8.
Claims43
A method of reducing flocculation in an immunogenic composition, where said immunogenic composition comprises (a) Haemophilus influenzae B capsular polysaccharide or oligosaccharide (PRP) and (b) at least one non-PRP antigen, said method comprising the steps of:
- (i) providing a first composition comprising a non-PRP antigen adsorbed onto an adjuvant with a zero point charge greater than 8;
- (ii) adding to said first composition a polyanionic polymer or a salt thereof, wherein said polymer is an oligopeptide or polypeptide consisting of, on average, 8-117 residues and consisting of anionic constitutional repeating units selected from a group consisting of L-aspartic acid and L-glutamic acid, to provide a second composition;
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- (iii) adding Haemophilus influenzae B capsular polysaccharide or oligosaccharide (PRP) to said second composition to provide a final immunogenic composition.
A method of reducing flocculation in an immunogenic composition, where said immunogenic composition comprises (a) Haemophilus influenzae B capsular polysaccharide or oligosaccharide (PRP) and (b) at least one non-PRP antigen, said method comprising the steps of:
- (i) providing a first composition comprising a non-PRP antigen adsorbed onto an adjuvant with a zero point charge greater than 8;
- (ii) adding to said first composition a second composition comprising Haemophilus influenzae B capsular polysaccharide or oligosaccharide (PRP) and a polyanionic polymer or a salt thereof, wherein said polymer is an oligopeptide or polypeptide consisting of, on average, 8-117 residues and consisting of anionic constitutional repeating units selected from a group consisting of L-aspartic acid and L-glutamic acid, to provide a final immunogenic composition.
The method of claim 38, where said stabilizing excipient is sucrose.
A kit comprising (i) a first composition comprising a Haemophilus influenzae B capsular polysaccharide or oligosaccharide (PRP) and a polyanionic polymer, and (ii) a second composition comprising a non-PRP antigen adsorbed onto an adjuvant with a zero point charge greater than 8.
Dependencies are inferred from the claim text.