Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof
Inventors
Emini, Emilio Anthony • Watson, Wendy Jo • Prasad, Avvari Krishna • Han, Mingming • Kim, Jin-Hwan • Gu, Jianxin • Yang, Yu-Ying • Kainthan, Rajesh Kumar • Cooper, David • Pride, Michael William • Jansen, Kathrin Ute
Assignees
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Publication Number
US-9492559-B2
Publication Date
2016-11-15
Expiration Date
Abstract
The present invention relates to new immunogenic compositions comprising conjugated Streptococcus pneumoniae capsular saccharide antigens (glycoconjugates) and uses thereof. Immunogenic compositions of the present invention will typically comprise at least one glycoconjugate from a S. pneumoniae serotype not found in PREVNAR®, SYNFLORIX® and/or PREVNAR 13®. The invention also relates to vaccination of human subjects, in particular infants and elderly, against pneumoccocal infections using said novel immunogenic compositions.
Core Innovation
The invention relates to an immunogenic composition comprising a Streptococcus pneumoniae serotype 22F glycoconjugate. The glycoconjugate comprises an isolated capsular polysaccharide from S. pneumoniae serotype 22F and a carrier protein, and has a molecular weight between 1000 kDa and 12,500 kDa. The ratio (w/w) of the polysaccharide to the carrier protein is between 0.4 and 2.
The disclosed composition characterizes quality-relevant properties of the glycoconjugate, including conjugate molecular-weight and Kd distributions, free (unconjugated) polysaccharide fraction, degree of conjugation via lysines on the carrier protein, saccharide-to-carrier w/w ratios, and acetate-related parameters that relate to O-acetylation. These include CL-4B column Kd distribution and comparative acetate-related parameters relative to the isolated polysaccharide.
The serotype 22F glycoconjugate is placed within pneumococcal conjugate vaccine immunogenic compositions using defined sets of S. pneumoniae capsular serotypes, including multivalent pneumococcal glycoconjugate compositions. The compositions can include selected carrier proteins and selected adjuvants, and the document describes formulation and administration contexts for humans, including medicament and vaccine formulation.
Claims Coverage
The claim coverage centers on an immunogenic composition defined by a serotype 22F glycoconjugate with constrained molecular weight and constrained polysaccharide-to-carrier protein ratio. Further inventive features include carrier protein selection, CL-4B Kd distribution and acetate ratio constraints, selected adjuvants, and a method of administering the composition to prevent, treat, or ameliorate S. pneumoniae infection/disease/condition.
Serotype 22F glycoconjugate with defined molecular weight and polysaccharide-to-carrier ratio
An immunogenic composition comprising a Streptococcus pneumoniae serotype 22F glycoconjugate, wherein the glycoconjugate has a molecular weight of between 1000 kDa and 12,500 kDa and comprises an isolated capsular polysaccharide from S. pneumoniae serotype 22F and a carrier protein, and wherein a ratio (w/w) of the polysaccharide to the carrier protein is between 0.4 and 2.
Carrier protein selection for the serotype 22F glycoconjugate
The immunogenic composition where the carrier protein is chosen from DT, TT, CRM197, other DT mutants, PD (Haemophilus influenzae protein D), or immunologically functional equivalents thereof.
CL-4B Kd distribution quality constraint
The immunogenic composition in which at least 30% of the glycoconjugates have a Kd of 0.3 or less when measured in a CL-4B column.
Acetate-to-polysaccharide ratio constraint
The immunogenic composition where the glycoconjugate has an acetate-to-polysaccharide ratio relative to the isolated polysaccharide that is at least 0.6.
Selected adjuvant types
An immunogenic composition in which at least one selected adjuvant is chosen from aluminum, calcium phosphate, liposomes, oil-in-water emulsions, and poly(D,L-lactide-co-glycolide) (PLG) microparticles or nanoparticles.
Method of preventing or treating pneumococcal disease
A method to prevent, treat, or ameliorate an S. pneumoniae infection/disease/condition in a subject by administering an effective amount of the immunogenic composition.
Overall, the claim set centers on the serotype 22F pneumococcal glycoconjugate composition and its defined quality and formulation parameters, together with a method of using the composition to prevent, treat, or ameliorate S. pneumoniae infection/disease/condition.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Use in prevention, treatment, or amelioration of an S. pneumoniae infection/disease/condition in a subject by administering an effective amount of the immunogenic composition.
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