Immunogenic compositions for use in pneumococcal vaccines

Patent metadata

Field	Value
Publication number	US-11413344-B2
Application number	US-201816478265-A
Country	US
Kind code	B2
Filing date	Jan 5, 2018
Priority date	Jan 20, 2017
Publication date	Aug 16, 2022
Grant date	Aug 16, 2022

Abstract

An object of the present invention is to provide immunogenic compositions for protection against S. pneumoniae, in particular against S. pneumoniae serogroup 18, while limiting the number of conjugates. The present invention therefore relates to new immunogenic compositions for use in pneumococcal vaccines and to vaccination of human subjects, in particular infants and elderly, against pneumoccocal infections using said immunogenic compositions.

First claim

The invention claimed is:

1. A method for preventing, treating, or ameliorating an infection, disease or condition caused by S. pneumoniae serotype 18A, 18B and/or 18F in a subject, said method comprising administering an immunogenic composition comprising:
(a) at least one glycoconjugate from S. pneumoniae serotype 18C capsular polysaccharide, wherein said glycoconjugate is prepared by reductive amination;
(b) glycoconjugates from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F capsular polysaccharides; and
(c) at least one glycoconjugate from S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F;
wherein said immunogenic composition comprises 0.5 μg to 20 μg of each polysaccharide, and does not comprise capsular saccharide from S. pneumoniae serotypes 18A, 18B and 18F; and
wherein said subject has previously received a 23-valent pneumococcal unconjugated polysaccharide vaccine.

2. The method of claim 1 , wherein said immunogenic composition comprises a 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25-valent pneumococcal conjugate composition.

3. The method of claim 1 , wherein said glycoconjugates are individually conjugated to CRM 197.

4. The method of claim 1 , wherein said glycoconjugate from S. pneumoniae serotype 18C comprises a saccharide which has a degree of O-acetylation ≤10%.

5. The method of claim 1 , wherein said immunogenic composition further comprises at least one adjuvant.

6. The method of claim 1 , wherein said immunogenic composition is able to elicit IgG antibodies in human which are capable of binding S. pneumoniae serotypes 18A, 18B and/or 18F polysaccharide at a concentration of at least 0.35 μg/ml as determined by ELISA assay.

7. The method of claim 1 , wherein said immunogenic composition is able to elicit functional antibodies in human which are capable of killing S. pneumoniae serotype 18A, 18B and/or 18F as determined by in vitro opsonophagocytic assay (OPA).

8. The method of claim 1 , wherein said immunogenic composition is able to elicit a titer of at least 1:8 against S. pneumoniae serotype 18A, 18B and/or 18F in at least 50% of the subjects as determined by in vitro opsonophagocytic killing assay (OPA).

9. The method of claim 1 , wherein said immunogenic composition is able to increase the proportion of responders against S. pneumoniae serotype 18A, 18B and/or 18F as compared to the pre-immunized population.

10. The method of claim 1 , wherein said immunogenic composition is able to increase the OPA titers of human subjects against S. pneumoniae serotype 18A, 18B and/or 18F as compared to the pre-immunized population.

Assignees

• Pfizer

Inventors

• Cooper David
• Jansen Kathrin Ute
• Pride Michael William

Classifications

• A61K2039/58

  raising an immune response against a target which is not the antigen used for immunisation · CPC title

• A61K2039/70

  Multivalent vaccine · CPC title

• A61K2039/6037

  Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT] · CPC title

• A61K39/092 Primary

  Streptococcus · CPC title

• A61P31/04

  Antibacterial agents · CPC title