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Vaccine

a polysaccharide and antigen technology, applied in the field of vaccines, can solve the problems of pneumonia polysaccharide vaccines (conjugated or not) being unable to protect against pneumonia, affecting the immune system, so as to achieve the effect of strengthening synergy

Inactive Publication Date: 2005-02-10
GLAXOSMITHKLINE BIOLOGICALS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Pneumococcal polysaccharide vaccines (conjugated or not) may not be able to protect against pneumonia in the elderly population for which the incidence of this disease is very high.
Antibody responses may also be impaired in the elderly.
Contrary to the normally accepted dogma, normal levels of anti-capsular polysaccharide antibodies may not be effective in complete clearance of bacteria, as pneumococci may invade host cells to evade this branch of the immune system.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

third embodiment

In a third embodiment there is provided a vaccine composition comprising a pneumococcal polysaccharide antigen and a Th1 adjuvant.

Streptococcus pneumoniae Polysaccharide Antigens of the Invention

Typically the Streptococcus pneumoniae vaccine of the present invention will comprise polysaccharide antigens (preferably conjugated), wherein the polysaccharides are derived from at least four serotypes of pneumococcus. Preferably the four serotypes include 6B, 14, 19F and 23F. More preferably, at least 7 serotypes are included in the composition, for example those derived from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. More preferably still, at least 11 serotypes are included in the composition, for example the composition in one embodiment includes capsular polysaccharides derived from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (preferably conjugated). In a preferred embodiment of the invention at least 13 polysaccharide antigens (preferably conjugated) are included, althou...

example 1

S.pneumoniae Capsular Polysaccharide:

The 11-valent candidate vaccine includes the capsular polysaccharides serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F which were made essentially as described in EP 72513. Each polysaccharide is activated and derivatised using CDAP chemistry (WO 95 / 08348) and conjugated to the protein carrier. All the polysaccharides are conjugated in their native form, except for the serotype 3 (which was size-reduced to decrease its viscosity).

Protein Carrier:

The protein carrier selected is the recombinant protein D (PD) from Non typeable Haemophilus influenzae, expressed in E. coli.

Expression of Protein D

Haemophilus influenzae protein D

Genetic construction for protein D expression

Starting Materials

The Protein D encoding DNA

Protein D is highly conserved among H. influenzae of all serotypes and non-typeable strains. The vector pHIC348 containing the DNA sequence encoding the entire protein D gene has been obtained from Dr. A. Forsgren, De...

example 2

Study of the Effect of Advanced Adjuvants on the Immunogenicity of the 11-Valent Pneumococcal PS-PD Conjugate Vaccine in Infant Rats

Infant rats were immunised with 11 valent pneumococcal PS-PD conjugate vaccine at a dosage of 0.1 μg each polysaccharide (made according to the method of Example 1), and using the following adjuvant formulations: none, AIPO4, 3D-MPL, 3D-MPL on AIPO4.

The formulation with only 3D-MPL was statistically (and surprisingly) more immunogenic (greatest GMC IgG) than for the other formulations for 5 out of 11 antigens. This was true both at high and low concentrations of 3D-MPL.

Opsonophagocytosis confirmed the GMC results.

Materials and Methods

Immunisation Protocol

Infant OFA rats were randomised to different mothers and were 7 days old when they received the first immunisation. They received 2 additional immunisations 14 and 28 days later. A bleed was performed on day 56 (28 days post III). All vaccines were injected s.c., and there were 10 rats per ...

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Abstract

The present invention relates to the field of bacterial polysaccharide antigen vaccines. In particular, the present invention relates to bacterial polysaccharides conjugated to protein D from H influenzae.

Description

FIELD OF INVENTION The present invention relates to bacterial polysaccharide antigen vaccines, their manufacture and the use of such polysaccharides in medicines. In particular the present invention relates to three inter-related aspects: A—vaccines comprising a pneumococcal polysaccharide antigen, typically a pneumococcal polysaccharide conjugate antigen, formulated with a protein antigen from Streptococcus pneumoniae and optionally a Th1 inducing adjuvant; B—specific, advantageous pneumococcal polysaccharide conjugates adjuvanted with a Th1 adjuvant; and C—bacterial polysaccharide conjugates in general conjugated to protein D from H. influenzae. BACKGROUND OF INVENTION Streptococcus pneumoniae is a Gram-positive bacteria responsible for considerable morbidity and mortality (particularly in the young and aged), causing invasive diseases such as pneumonia, bacteremia and meningitis, and diseases associated with colonisation, such as acute Otitis media. The rate of pneumococcal pne...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61KA61K35/74A61K39/00A61K39/09A61K39/005A61K39/02A61K39/04A61K39/05A61K39/085A61K39/095A61K39/102A61K39/112A61K39/116A61K39/155A61K39/385A61K39/39A61PA61P11/00A61P27/06A61P31/04A61P37/04C07K14/285C12N15/09
CPCA61K39/092A61K39/095A61K39/102A61K39/155A61K2039/55505Y10S424/831A61K2039/6037A61K2039/6068A61K2039/6075A61K47/4833A61K2039/70A61K2039/55572A61K39/12A61K47/646A61P11/00A61P27/06A61P27/16A61P31/00A61P31/04A61P37/04Y02A50/30A61K39/385
Inventor CAPIAU, CARINEDESCHAMPS, MARGUERITEDESMONS, PIERRE MICHELLAFERRIERE, CRAIG ANTONYJOSEPHPOOLMAN, JANPRIEELS, JEAN-PAUL
Owner GLAXOSMITHKLINE BIOLOGICALS SA
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