Immunogenic compositions and uses thereof
Inventors
Anderson, Annaliesa Sybil • Bagle, Leena Shriram • Bhupender Bhalla, Amardeep Singh • Garcia, Miguel Angel • Hu, Lei • Khandke, Lakshmi • Prasad, Avvari Krishna • Yang, Cindy Xudong
Assignees
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Publication Number
US-12527855-B2
Publication Date
2026-01-20
Expiration Date
Abstract
The invention relates to immunogenic compositions comprising a capsular polysaccharide (CP) from Streptococcus agalactiae, commonly referred to as group B Streptococcus (GBS), conjugated to a carrier protein, and optionally including an aluminum-based adjuvant. The invention further relates to methods for inducing an immune response in subjects against GBS and/or for reducing or preventing invasive GBS disease in subjects using the compositions disclosed herein. The resulting antibodies can be used to treat or prevent GBS infection via passive immunotherapy.
Core Innovation
The invention relates to a method of immunizing a pregnant subject for preventing or reducing a disease or condition associated with group B Streptococcus (GBS) in an infant. The method includes administering an immunogenic composition that comprises polysaccharide-carrier protein conjugates, where each conjugate comprises a capsular polysaccharide from a different serotype of GBS conjugated to a carrier protein, with the serotypes comprising Ia, Ib, II, III, IV, and V.
Each capsular polysaccharide has a sialic acid level greater than 60 percent, and the carrier protein comprises a diphtheria toxoid or CRM197. The immunogenic composition further comprises one or more of a pharmaceutically acceptable excipient, buffer, stabilizer, adjuvant, a cryoprotectant, a salt, a divalent cation, a non-ionic detergent, an inhibitor of free radical oxidation, a carrier, or a mixture thereof.
Maternal immunization induces an immune response against GBS in an infant. The provided material also describes characterization related to GBS capsular polysaccharide and antibody responses, and documents use of GBS polysaccharide-specific monoclonal antibodies in immunodiagnostics and passive immunotherapy/prophylaxis against streptococcal infection.
Claims Coverage
The independent claims cover maternal immunization using a multi-serotype GBS capsular polysaccharide-carrier protein conjugate composition, constrained by serotype set (Ia, Ib, II, III, IV, V), sialic acid level (>60%), and carrier protein (diphtheria toxoid or CRM197), with optional specified pharmaceutically acceptable formulation components. The claims frame the use as preventing or reducing infant disease or conditions associated with GBS or as inducing an immune response in an infant.
Maternal immunization with defined GBS serotype conjugate composition
A method of immunizing a pregnant subject by administering an immunogenic composition comprising polysaccharide-carrier protein conjugates, wherein each conjugate comprises a capsular polysaccharide from a different serotype of GBS conjugated to a carrier protein, and wherein the serotypes comprise Ia, Ib, II, III, IV, and V.
High sialic acid polysaccharides and diphtheria toxoid/CRM197 carrier
Each capsular polysaccharide has a sialic acid level greater than 60 percent and the carrier protein comprises a diphtheria toxoid or CRM197.
Immunogenic composition with pharmaceutically acceptable formulation components
The immunogenic composition further comprises one or more of a pharmaceutically acceptable excipient, buffer, stabilizer, adjuvant, a cryoprotectant, a salt, a divalent cation, a non-ionic detergent, an inhibitor of free radical oxidation, a carrier, or a mixture thereof.
Inducing an immune response in an infant through maternal immunization
A method of inducing an immune response against group B Streptococcus (GBS) in an infant through maternal immunization of a pregnant subject by administering the immunogenic composition comprising polysaccharide-carrier protein conjugates as defined by the conjugates, sialic acid level, carrier protein, and optional formulation components.
The independent claims cover maternal immunization using a multi-serotype GBS capsular polysaccharide-carrier protein conjugate composition with specified serotypes, sialic acid level, and carrier protein, together with optional pharmaceutically acceptable formulation components. The claims cover preventing or reducing GBS-associated disease or conditions in an infant and inducing an immune response against GBS in an infant.
Stated Advantages
Preventing or reducing a disease or condition associated with group B Streptococcus (GBS) in an infant.
Inducing an immune response against group B Streptococcus (GBS) in an infant through maternal immunization.
Reducing GBS carriage.
Documented Applications
Maternal immunization of a pregnant subject to prevent or reduce GBS-associated disease or conditions in an infant, including invasive GBS disease, with early-onset and late-onset forms.
Maternal immunization to induce an immune response against GBS in an infant.
Immunodiagnostic use of anti-polysaccharide binding specificity monoclonal antibodies.
Passive immunotherapy/prophylaxis against streptococcal infection.
Use of immunogenic compositions and vaccine use for inducing immune responses against GBS or associated disease in subjects, including pregnant females.
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