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Streptococcus pneumoniae vaccine

A Streptococcus pneumoniae and vaccine technology, which is applied in the directions of antibacterial drugs, bacterial antigen components, carrier-binding antigen/hapten components, etc., can solve the problems of single polysaccharide conjugates and technical difficulties, etc.

Inactive Publication Date: 2005-07-06
GLAXOSMITHKLINE BIOLOGICALS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Therefore, it is technically difficult to combine multiple polysaccharide conjugates into a single, effective vaccine formulation

Method used

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  • Streptococcus pneumoniae vaccine
  • Streptococcus pneumoniae vaccine
  • Streptococcus pneumoniae vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Determination of polysaccharides that modulate the immune response with age

[0066] Data on human antibody titers to polysaccharide (unconjugated) before and after immunization (2 weeks - 3 months) were collected in-house or via external sources. Figure 1 shows the relationship between the immunogenicity of polysaccharides of each serotype, as measured by the geometric mean doubling (GFI) of antibody titers after immunization with polysaccharides, and the mean age of the study subjects . A linear relationship between the logarithm of the geometric mean doubling and age can indicate whether the immune response is modulated with age. As shown in Figure 1, serotypes 6, 14, 19 and 23 were significantly correlated with age (p or = 0.20).

Embodiment 2

[0068] General Method for Determining Antibody Responses in Various Mammals

[0069] IgG antibodies against Streptococcus pneumoniae polysaccharides in serum were tested by ELISA, which was based on the consensus human serum test recommended by the 1994-1996 joint CDC / WHO symposium (WHO 1996 , Plikatis et al. J. Clin. Mierobiol 38:2043 (2000)). Briefly, purified intaglan purchased from ATCC (Rockyille, Md, 20852) was plated at 25 μg / ml in phosphoryl buffered saline (PBS) on high-binding microtiter plates (Nunc Maxisorp) at 4°C. be overnight. Microtiter plates were blocked with fetal calf serum (FCS) for 1 hour at 37°C. Serum samples were preincubated with 20 μg / ml cell wall polysaccharides (Statens Serum Institute, Copenhagen) and 10% FCS for 30 minutes at room temperature to neutralize antibodies against the antigen. Control serum 89SF (gifted from Dr. C Frasch, USFDA) was treated in the same way and included on each plate. Samples were then diluted two-fold with 10% FCS ...

Embodiment 3

[0083] Effect of Streptococcus pneumoniae PS-PD conjugate combination on immunogenicity in adult rats

[0084] It has been observed that combining vaccines into multivalent formulations may result in a reduction in the immunogenicity of one or more components of the vaccine. This is especially observed in conjugate vaccines and is called vector-induced epitope suppression. The mechanism causing this inhibition is not well understood but tends to occur at higher doses of carrier protein.

[0085] The 11-valent S. pneumoniae conjugate vaccine is an example of a combination vaccine. Because the combination of conjugates of various serotypes will increase the total amount of protein used for immunization, it will be important to determine whether the combination of each conjugate vaccine into a multivalent formulation will result in a significant reduction in the immunogenicity of the conjugates.

[0086] Program:

[0087] Adult rats were immunized with a conjugate vaccine of S...

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Abstract

The present invention provides an optimal formulation of multi-serotype Streptococcus pneumoniae conjugate vaccine.

Description

Technical field: [0001] The present invention relates to an improved Streptococcus pneumonia vaccine. Background technique: [0002] Children under 2 years of age do not mount an immune response to most polysaccharide vaccines, so immunogenic polysaccharides must be produced by chemical conjugation to protein carriers. Coupling a polysaccharide (a T-independent antigen) to a protein (a T-dependent antigen) confers thymus-dependent properties on the polysaccharide, including isotype switching, affinity maturation, and memory induction. [0003] However, repeated applications of polysaccharide-protein conjugates or combining polysaccharide-protein conjugates into multivalent vaccines can be problematic. For example, a dose-range trial of a Haemophilus influenzae type b polysaccharide (PRP) vaccine with tetanus toxoid as a protein carrier, in combination with (free) TT and S. pneumoniae polysaccharide, has been reported. The -TT conjugate vaccine was immunized concurrently ac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61KA61K39/09A61K39/00A61K39/116A61K39/385A61P11/00A61P31/04
CPCA61K39/092A61K2039/6037A61K2039/6068A61P11/00A61P31/04A61K39/385A61K39/09
Inventor C·A·J·拉菲里雷J·普尔曼
Owner GLAXOSMITHKLINE BIOLOGICALS SA
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