Multivalent pneumococcal conjugate vaccine
Inventors
Matur, Ramesh Venkat • Thirumeni, Nagarajan • Burki, Rajendar • Mantena, Narender Dev • Datla, Mahima
Assignees
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Publication Number
US-11147863-B2
Publication Date
2021-10-19
Expiration Date
Abstract
The present invention relates to a multivalent Pneumococcal conjugate vaccine (PCV) composition comprising: 1) at least 12 capsular polysaccharides selected from serotypes 1, 3, 4, 5, 6B, 7F, 9N, 9V, 15B, 14, 18C, 19A, 19F, 22F, 23F and 33F of S. pneumoniae activated with CDAP and conjugated to carrier protein selected from CRM197, pneumococcal surface protein A (PspA), pneumococcal adhesin protein (PsaA) or combination thereof and 2) a pharmaceutically acceptable carrier, wherein the composition does not contain capsular polysaccharide from serotype 6A.
Core Innovation
The invention relates to a multivalent Pneumococcal conjugate vaccine (PCV) composition comprising capsular polysaccharides from Streptococcus pneumoniae. The capsular polysaccharides are CDAP-activated and conjugated to CRM197, and are formulated with a pharmaceutically acceptable carrier.
The PCV composition is defined as containing capsular polysaccharides from specified serotypes, including 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F. The composition does not contain capsular polysaccharide from serotype 6A.
The document further describes a rationale for excluding serotype 6A in order to leverage cross-reactivity between 6A and 6B while enabling broader serotype coverage. Preferred formulation valencies are described as 13, 14, or 15 valent sets, together with immunogenicity evaluation in rabbits comparing formulations to Prevnar 13 and placebo using ELISA IgG titers referenced in figures 1–5.
Claims Coverage
The identified claims are directed to a multivalent PCV composition with CDAP-activated, CRM197-conjugated capsular polysaccharides from specified serotypes, while excluding serotype 6A. The inventive features are further refined by dependent claims with quantitative constraints for polysaccharide amounts, CRM197 amounts, and a defined single 0.5 mL dose formulation.
Multivalent PCV composition with specified CDAP-activated CRM197 conjugates
A multivalent Pneumococcal conjugate vaccine (PCV) composition consisting of 14 capsular polysaccharides from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F of S. pneumoniae activated with CDAP and conjugated to CRM197, and a pharmaceutically acceptable carrier.
PCV composition excludes serotype 6A polysaccharide
The PCV composition wherein the PCV composition does not contain capsular polysaccharide from serotype 6A.
Per-serotype capsular polysaccharide quantitative range
The PCV composition wherein each of the 14 capsular polysaccharides is present in an amount of 1 to 10 µg.
Quantitative range for CRM197 conjugated to polysaccharides
The PCV composition wherein the amount of CRM197 conjugated to the 14 capsular polysaccharides is 3 to 30 µg.
Defined single-dose (0.5 mL) quantitative formulation with aluminum phosphate adjuvant
A single 0.5 mL dose comprises 2 µg of each of the 14 capsular polysaccharides, 30 to 40 µg of CRM197, and 0.2 to 1 mg of aluminum phosphate adjuvant, sodium chloride, and a buffer.
The core coverage is for a multivalent PCV composition with specified CDAP-activated capsular polysaccharides conjugated to CRM197, formulated with a pharmaceutically acceptable carrier and specifically lacking serotype 6A polysaccharide. Dependent claims narrow the subject matter with per-serotype polysaccharide amounts, the CRM197 conjugate amount, and quantitative single-dose (0.5 mL) component ranges including aluminum phosphate adjuvant, sodium chloride, and a buffer.
Stated Advantages
Exclusion of serotype 6A to leverage cross-reactivity between 6A and 6B while enabling broader serotype coverage.
Documented Applications
Immunogenicity evaluation in rabbits comparing formulations A/B/C to Prevnar 13 and placebo, with ELISA IgG titers referenced in figures 1–5.
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