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Clostridium difficile multi-component vaccine

A Clostridium difficile and Clostridium difficile toxin technology, applied in the field of vaccine administration and Clostridium difficile vaccine, can solve the problems of reduced recurrence rate of CDI and low effectiveness of anti-hypertoxic Clostridium difficile strains

Pending Publication Date: 2021-08-31
MATRIVAX
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The FDA has approved Merck's monoclonal antibody targeting Clostridium difficile toxin B (bezlotoxumab) (Zinplava TM ) is used in combination with antibiotic therapy to treat patients with CDI to prevent recurrent CDI, but Zinplava TM Only partially effective in improving CDI-associated symptoms, less effective against hypervirulent C. difficile strains, and only ~40% reduction in CDI recurrence observed in patients with CDI

Method used

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  • Clostridium difficile multi-component vaccine
  • Clostridium difficile multi-component vaccine
  • Clostridium difficile multi-component vaccine

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0114] Preparation of immunogenic compositions

[0115] The immunogenic composition according to the invention can be prepared by simply admixing component (a) which is, for example, a suspension of inactivated whole cells of Clostridium difficile or a CSP preparation with component (b) (eg resuspended particles), the component (b) is eg a solution of at least one toxin A or B toxoid and / or at least one non-toxic C. difficile toxin A or toxin B polypeptide. Appropriate ratios of components (a) and (b) can be determined by a person skilled in the art. In certain embodiments, sufficient inactivated whole cell (WC) or cell surface extract (CSE) component (a) should be used to provide 10 7 -10 11 cells or 10-100 μg of CSE; and enough toxoid / toxin polypeptide fragment component (b) should be used to provide 4-500 μg of toxoid or non-toxic polypeptide fragment. Other amounts may be used if multiple immunizations are envisaged. The amounts of the components can be adjusted inde...

Embodiment 1

[0170] A sample of Clostridium difficile BI / NAP1 / 027 strain was obtained from the American Type Culture Collection, Manassas, VA ( BAA-1870) obtained. The glycerol stock was used to inoculate a 50 mL brain heart infusion-L-cysteine ​​(BHI-Cys) growth medium starter culture (BHI-BD Bacto #237200) grown overnight at 37 °C for 17 hours under anaerobic conditions. ; L-cysteine-Sigma #168149). Optical density (OD 600 ) read and contamination test. Inoculate 1 L of freshly reduced BHI-Cys medium with starter culture to an OD of 0.1 600 and incubated anaerobically at 37°C until an OD of about 1.0 was reached 600 (5-6 hours of growth). Cells were harvested by centrifugation (6000 rpm, 20 min, 4°C) and washed three times with IX PBS. After the last wash, the pellet was resuspended in 1X PBS and serial dilutions were prepared to determine the number of colony forming units (CFU) by plating; 600 Readout for cell counts. The pellet suspension was divided into two equal volumes fo...

Embodiment 2

[0179] In experiments evaluating protection against toxin BHV challenge, CROPB HV The immunized mice were completely protected from toxin challenge (10 out of 10 mice), whereas toxoid B HV Eight out of 10 mice immunized were protected from toxin challenge (Table 3; figure 2 ). These data suggest that CROPB HV is the preferred antigen, equivalent to or superior to full-length inactivated toxin B HV .

[0180]

[0181]

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Abstract

Immunogenic compositions for combating clostridium (C.) difficile infection are disclosed comprising an admixture of at least two components (a) and (b), where component (a) comprises inactivated cells of at least one strain of C. difficile, or or cell surface extracts (CSE) from one or more strains of C. difficile bacteria; and component (b) comprises at least one toxoid or a non-toxic, immunogenic polypeptide fragment of a C. difficile Toxin A or Toxin B. Administration of the immunogenic composition is effective to elicit an immune response in a subject immunized with said composition to produce antibodies reactive with at least one C. difficile strain and at least one C. difficile toxin.

Description

[0001] Related Application and Incorporation by Reference [0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 768,220, filed November 16, 2018. [0003] The above application and all documents cited therein or during its prosecution (“Application Cited Documents”), and all documents cited or referenced in documents cited in this Application, and all documents cited or referenced herein (“herein Documents cited"), and all documents cited or referenced in documents cited herein, as well as any manufacturer's instructions, descriptions, product specifications and product Inserts, all incorporated herein by reference, may be used to practice the invention. More specifically, all referenced documents are incorporated by reference to the same extent as if each individual document was expressly and individually indicated to be incorporated by reference. technical field [0004] The present invention relates to immunogenic compositions, me...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/08
CPCA61K39/08A61K2039/521A61K2039/55505A61P31/04A61K45/06
Inventor 凯文·基林托马斯·格里芬
Owner MATRIVAX
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