Multivalent pneumococcal conjugate vaccine
AssigneeBiological E Limited
InventorsRamesh Venkat Matur, Nagarajan Thirumeni, Rajendar Burki, Narender Dev Mantena, Mahima Datla
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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.
Claims11
A multivalent Pneumococcal conjugate vaccine (PCV) composition comprising:
- a) 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
- b) a pharmaceutically acceptable carrier, wherein the composition does not contain capsular polysaccharide from serotype 6A.
A multivalent Pneumococcal conjugate vaccine (PCV) composition comprising:
- a) at least 14 capsular polysaccharides selected from serotypes 1, 3, 4, 5, 6B, 7F, 9N, 9V, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F of S. pneumoniae activated with CDAP and conjugated to CRM197,PspA, PsaA or combination thereof and
- b) a pharmaceutically acceptable carrier, wherein the composition does not contain capsular polysaccharide from serotype 6A.
A 14 valent sterile liquid Pneumococcal conjugate vaccine (PCV) formulation comprising 2 μg of each capsular polysaccharides of serotypes 1, 3,.4, 5, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F, 4 μg of serotype 6B each individually conjugated to about 32 μg CRM197;
- 0.125 mg of elemental aluminum (0.5 mg aluminum phosphate) adjuvant;
- and sodium chloride and L-histidine buffer, wherein the formulation does not contain capsular polysaccharide from serotype 6A.
A 13 valent sterile liquid Pneumococcal conjugate vaccine (PCV) formulation comprising 2 μg of each capsular polysaccharides of serotypes 1, 3, 4, 5, 7F, 9V, 14, 18C, 19A, 19F, 22F and 33F, 4 μg of serotype 6B each individually conjugated to about 32 μg CRM197;
- 0.125 mg of elemental aluminum (0.5 mg aluminum phosphate) adjuvant;
- and sodium chloride and L-histidine buffer, wherein the formulation does not contain capsular polysaccharide from serotype 6A.
A 13 valent sterile liquid Pneumococcal conjugate vaccine (PCV) formulation comprising 2 μg of each capsular polysaccharides of serotypes 1, 3, 4, 5, 7F, 9V, 14, 18C, 19A, 19F, 23F and 33F, 4 μg of serotype 6B each individually conjugated to about 32 μg of CRM197;
- 0.125 mg of elemental aluminum (0.5 mg aluminum phosphate) adjuvant;
- and sodium chloride and L-histidine buffer, wherein the formulation does not contain capsular polysaccharide from serotype 6A.
A serotype composition for formulating a 13 valent PCV comprising;
- a) conjugation of the pneumococcal capsular polysaccharides of known size from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 33F activated utilizing CDAP, individually to an immunogenic carrier protein CRM197,
- b) diafiltration of the individual monovalent pneumococcal conjugates followed by purification using size exclusion chromatography,
- c) analysis of the fractions by SEC-HPLC and pooling of fractions containing monovalent pneumococcal conjugates before filter sterilization using 0.2 μm filter,
- d) formulation of the 13 valent PCV using 13 monovalent pneumococcal conjugates;
- 4.4 μg for serotype 6B;
- 2.2 μg for rest of the serotypes and Adju-Phos® adjuvant together with appropriate excipient and buffer followed by aseptic filling,
- e) wherein the said 13 valent PCV does not contain capsular polysaccharide from serotype 6A.
A serotype composition for formulating a 14 valent PCV comprising;
- a) conjugation of pneumococcal capsular polysaccharides of known size from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F activated utilizing CDAP, individually to an immunogenic carrier protein CRM197,
- b) diafiltration of the individual monovalent pneumococcal conjugates followed by purification using size exclusion chromatography,
- c) analysis of the fractions by SEC-HPLC and pooling of fractions containing monovalent pneumococcal conjugates before filter sterilization using 0.2 μm filter and
- d) formulation of the 14 valent PCV using monovalent pneumococcal conjugates;
- 4.4 μg for serotype 6B;
- 2.2 μg for rest of the serotypes and Adju-Phos® adjuvant together with appropriate excipient and buffer followed by aseptic filling.
Dependencies are inferred from the claim text.