Semi-synthetic meningococcal conjugate vaccine
Inventors
Goel, Akshay • Renukuntla, Santosh • Kowlakuntla, Eswara • Datla, Mahima • Mantena, Narender Dev
Assignees
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Publication Number
US-11420993-B2
Publication Date
2022-08-23
Expiration Date
Abstract
The present invention relates to novel semi-synthetic meningococcal conjugate vaccine comprising novel synthetic oligosaccharide conjugated to a carrier protein. The present invention also relates to novel synthetic meningococcal oligosaccharide and a process for its preparation.
Core Innovation
The invention relates to a semisynthetic meningococcal C conjugate vaccine that comprises a synthetic meningococcal C oligosaccharide conjugated to a carrier protein to form a conjugate having Formula (II). The synthetic meningococcal C oligosaccharide is defined by specific structural variables including m and n, and the conjugate includes a linkage system in which L1 is a moiety derived from a crosslinking reagent and L2 is selected as specified in the claim.
The synthetic meningococcal C oligosaccharide is prepared as sialylated products extending from dimer through tetrasialoside, including higher-order sialylated structures corresponding to higher-order sialic acid units. The synthetic oligosaccharide is subsequently converted for conjugation by carrier-protein derivatization and oligosaccharide activation/conjugation via thiol chemistry.
Carrier protein embodiments explicitly include CRM197, diphtheria toxoid, and tetanus toxoid, and the conjugate is positioned as a route toward a T-cell dependent antigen response. The platform is further extended to pharmaceutical compositions and broader Neisseria meningitidis serogroups, including serogroups A, W135, and Y conjugated to carrier proteins with pharmaceutically acceptable excipients and optional vaccine adjuvant.
Claims Coverage
The claim set provides one independent claim to a semisynthetic meningococcal C conjugate vaccine, with dependent claims refining the carrier protein selections and expanding into pharmaceutical composition embodiments and quantitative composition constraints. The claims present 6 inventive features.
Semisynthetic MenC oligosaccharide conjugated to carrier protein via crosslinking-derived moiety
A semisynthetic meningococcal C conjugate vaccine comprising a synthetic meningococcal C oligosaccharide conjugated to a carrier protein to form the semisynthetic meningococcal C conjugate vaccine having Formula (II), wherein the linkage system includes L1 as a moiety derived from a crosslinking reagent and L2 as specified in the claim.
Carrier protein selection from tetanus toxoid, diphtheria toxoid, or CRM197
The semisynthetic meningococcal C conjugate vaccine wherein the carrier protein is selected from tetanus toxoid, diphtheria toxoid, or CRM197.
Pharmaceutical composition comprising the semisynthetic MenC conjugate vaccine
A pharmaceutical composition comprising the semisynthetic meningococcal C conjugate vaccine together with a pharmaceutically acceptable carrier.
Multivalent meningococcal composition including serogroups A, W135, or Y conjugates
A pharmaceutical composition including a Neisseria meningitidis polysaccharide for serogroups A, W135, or Y conjugated to a carrier protein.
Optional vaccine adjuvant in the pharmaceutical composition
The pharmaceutical composition including a vaccine adjuvant.
Quantitative ranges for A, Y, and W135 polysaccharide conjugates and carrier protein amounts
A pharmaceutical composition including polysaccharides for meningococcal serogroups A, Y, and W135, each present at about 1 µg to about 10 µg and individually conjugated to about 5 µg to about 20 µg of a carrier protein.
The core inventive concept is the semisynthetic meningococcal C conjugate vaccine built from a synthetic MenC oligosaccharide conjugated to a carrier protein using a crosslinking-derived moiety within Formula (II), with dependent claims specifying carrier protein choices and expanding into multivalent pharmaceutical compositions for serogroups A, W135, and Y, including optional adjuvant and dose/conjugation range constraints.
Stated Advantages
Synthetic, homogeneous production.
Reduced purification.
High conjugation yields.
Conversion to T-cell dependent antigen.
Smaller oligomers enabling different carrier proteins.
Synthetic manufacture of the polysaccharide and higher-order sialylated products, enabling use in the semisynthetic conjugate vaccine.
High-yield thiol-based conjugation for producing the semisynthetic meningococcal C conjugate vaccine.
Documented Applications
A semisynthetic meningococcal C conjugate vaccine, including pharmaceutical compositions and multivalent serogroups A, W135, and Y conjugate compositions with pharmaceutically acceptable excipients and optional vaccine adjuvant.
Immunogenicity characterization in mice for the semisynthetic meningococcal C conjugate vaccine, including ELISA IgG response and Serum Bactericidal Assay (SBA) functional bactericidal activity.
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