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Glycoconjugate vaccines for use in immune-compromised populations

A technology of immunocompromised and glycoconjugates, which is applied in the direction of drug combinations, medical preparations containing active ingredients, allergic diseases, etc., can solve the problem of inability to produce effective immune responses, failure to show that immunocompromised patients are effective, immunogenic gender issues

Inactive Publication Date: 2005-07-13
GLAXOSMITHKLINE BIOLOGICALS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, bacterial antigens such as staphylococcal and enterococcal polysaccharide antigens are known to be poorly immunogenic
Their immunogenicity can be enhanced by conjugation to protein carriers, but none of the currently available conjugate vaccines have been shown to be effective in immunocompromised patients, and the notion that these vaccines do not elicit an effective immune response in immunocompromised populations has been widely accepted

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0052] Example 1: Staphylococcus aureus type 5 / type 8 polysaccharide vaccine dosing study in ESRD patients

[0053] Twenty male patients with end-stage renal disease (ESRD) maintained on chronic ambulatory peritoneal dialysis or hemodialysis each received a single intramuscular injection of a synthetic vaccine containing a target dose of 25 micrograms each in the form of recombinant sham Type 5 and Type 8 S. aureus CPS of extracellular protein (rEPA) conjugates. This 25 microgram dose is the same as that used in healthy subjects. Because the immune response is expected to be weak in this chronically ill population, a second dose of 0.5 mL of the bivalent vaccine was administered six (6) weeks after the initial dose. An additional five (5) healthy adult males received an equal volume of saline placebo. Levels of IgG against CPS types 5 and 8 were assessed before injection and 2 and 6 weeks after injection.

[0054] As shown in Table 1, a true immune response was observed in ...

example 2

[0059] Example 2: Protection of ESRD patients with S. aureus type 5 / type 8 polysaccharide vaccine

[0060] Patients were recruited at 73 dialysis centers in California. Inclusion criteria were: ESRD patients ≥18 years of age, on hemodialysis for at least 8 weeks prior to enrollment using natural vascular fistula or synthetic / xenograft access, with a Karnofsky score of at least 50 at enrollment, and expected to be able to complete all Necessary follow-up visits. Exclusion criteria were: symptoms and signs consistent with infection within 2 weeks prior to immunization, history of HIV infection, allergies or previous allergic reactions to polysaccharide or polysaccharide conjugate vaccines, drug abuse in the past year, use of immunosuppressive or Immunomodulatory drugs, and having a malignancy or treating a malignancy within 6 months prior to vaccination.

[0061] Eligible patients were randomly assigned to receive the vaccine or a placebo. Categorical randomization was perfor...

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Abstract

Disclosed herein are staphylococcal and enterococcal glycoconjugate vaccines for the prevention or treatment of bacterial infections in immunocompromised individuals. The vaccine consists of an immunizing vector and a conjugate of a polysaccharide or glycopeptide surface antigen from a clinically pathogenic bacterial strain. The vaccine can be used for active protection of immunocompromised individuals in settings where there is an immediate risk of bacterial infection, such as during intubation or surgery.

Description

Background of the invention [0001] A.Technical field [0002] The present invention generally relates to the use of staphylococcal and enterococcal glycoconjugate vaccines to prevent or treat bacterial infections in immunocompromised individuals. [0003] B. Background technology [0004] In healthy individuals, staphylococci and enterococci rarely cause systemic infections and are therefore considered opportunistic pathogens. Normal adults and animals with well-established immune systems acquire natural resistance to these bacterial infections through various mechanisms. In addition to possible immunological mechanisms, the mucosal and skin barriers are involved. Damage to these natural barriers due to injury, such as burns, trauma, or surgery with indwelling medical devices, increases the risk of staphylococcal and enterococcal infections. In addition, individuals with compromised immune responses, such as cancer patients undergoing chemotherapy and radiation, people wit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/085A61P31/04
CPCA61K39/085A61K2039/6037A61P31/04A61P37/02A61P37/04A61P43/00A61K39/116
Inventor A·I·法托姆R·B·纳索
Owner GLAXOSMITHKLINE BIOLOGICALS SA
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