Borrelia burgdorferi bacterin

a bacterin and borrelia technology, applied in the field of borrelia burgdorferi bacterin, can solve the problems of hampered establishment of protocols for effective chemical treatment of lyme disease, long-term infection, and difficulty in detecting spirochetes in affected tissues, so as to enhance the immunogenicity of inactivated borrelia burgdorferi, and enhance the immunogenicity of inactiv

Inactive Publication Date: 2008-01-31
SCHERING CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0012] This invention also provides a bacterin which comprises per dose an effective immunizing amount of two non-cross protective isolates of inactivated Borrelia burgdorferi and one or more antigenic subunits from the non-crossprotective isolates, an adjuvant in an amount effective to enhance the immunogenicity of the inactivated Borrelia burgdorferi and antigenic subunits and a suitable carrier.
[0014] The invention also provides for the use of a bacterin which comprises an effective immunizing amount of at least two non-crossprotective isolates of inactivated Borrelia burgdorferi and one or more antigenic subunits from the non-crossprotective isolates, an adjuvant in an amount effective to enhance the immunogenicity of the inactivated Borrelia burgdorferi and antigenic subunits and a suitable carrier for the immunization of animals against infection by Borrelia burgdorferi.

Problems solved by technology

The B. burgdorferi spirochetes reside in various tissues of the host animal, where they may lead to long term infection.
Adding to these diagnostic complications is the difficulty of detecting the spirochetes in affected tissues.
However, the establishment of protocols for effective chemical treatment of Lyme disease has been hampered by the lack of data with which an appropriate time period for treatment could be established.
Additionally, there has been a lack of studies of the effectiveness of drugs in human patients.

Method used

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  • Borrelia burgdorferi bacterin

Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of Borrelia Burgdorferi Bacterin

Equipment Needed:

[0062] Sterile: 20 ml tubes, 250 ml bottles and 10 liter jugs; 200, 500 or 3,000 liter fermenter; serological pipets; magnets; mixing and storage tanks; and centrifuge.

[0063] Nonsterile: magnetic stirring motors; pipet aids; peristaltic pumps; tubing and tubing clamps; Petroff / Hauser counting chamber; darkfield microscope; coveralls, gloves, hats, masks, shoe covers and face shields; micropipet and micropipet tips; saline solution blanks.

[0064] Microorganisms used: Two isolates of Borrelia burgdorferi are used in the preparation of the product, B. burgdorferi isolates C-1-11 and S-1-10 obtained from Dr. Steven M. Callister, Gundersen Medical Foundation, La Crosse, Wis. The bacterin will contain adjusted counts of each Borrelia isolate culture to satisfy potency standard requirements.

[0065] Identity of each microorganism and frequency of methods of identification: Identification is made on the basis of morphological a...

example 2

Preparation of the Product

[0081] Method of inactivation: The production growth is inactivated with binary ethyleneimine (BEI). Inactivation is conducted at 32° C.±2° C. The appropriate amount of BEI is prepared as a 0.344 M (7.05%) solution. A 7.05% BEI solution is prepared by dissolving 70.48 grams of 2-bromoethylamine hydrobromide (molecular weight 204.89) and 8.00 grams NaOH (MW 40.00) in one liter of deionized water. The dissolved solution is incubated at 37° C. for two hours and then added to the culture at 30 ml per liter under constant agitation (slow stirring). The inactivation is conducted for no less than 24 hours at a pH of 7.3±0.2 with agitation (slow stirring). Upon completion of inactivation, the BEI is neutralized by the addition of sterile sodium thiosulfate. The appropriate amount of sterile sodium thiosulfate solution is prepared as a 3.015 M (47.7%) solution by dissolving 477.0 grams sodium thiosulfate in one liter of deionized water. This solution is filtered th...

example 3

Testing of the Bacterin

[0097] Purity: Each serial or subserial is tested for bacteria and fungi in accordance with 9 C.F.R. §113.26.

[0098] Safety: Safety testing is conducted on bulk or final containers in accordance with 9 C.F.R. §§ 113.38 and 113.40 wherein a dog safety test is conducted using a 2× (2 cc) dose given by IM injection.

[0099] Potency: Potency testing is conducted on assembled bulk or final containers. Potency testing is conducted using an antigen capture ELISA. Satisfactory serials must have a relative potency of ≧1.0 as determine by the U.S. Department of Agriculture, Veterinary Biologics Program's Relative Potency Calculations Software, Version 3.0.

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Abstract

A bacterin including effective immunizing amounts of two non-crossprotective isolates of inactivated Borrelia burgdorferi, an adjuvant in an amount effective to enhance the immunogenicity of the inactivated Borrelia burgdorferi isolates and a suitable carrier is provided herein. The bacterin may also contain a third non-crossprotective isolate. A bacterin including effective immunizing amounts of an antigenic subunit derived from a first Borrelia burgdorferi isolate and a second, non-crossprotective Borrelia burgdorferi isolate, an adjuvant in an amount effective to enhance the immunogenicity of the antigenic subunits and a suitable carrier is also provided. The bacterin may also contain an effective immunizing amount of an antigenic subunit of a third Borrelia burgdorferi. Further provided is a bacterin which includes effective immunizing amounts of two non-crossprotective isolates of inactivated Borrelia burgdorferi and one or more antigenic subunits from the non-crossprotective isolates, an adjuvant in an amount effective to enhance the immunogenicity of the inactivated Borrelia burgdorferi and antigenic subunits and a suitable carrier.

Description

BACKGROUND OF THE INVENTION [0001] Lyme disease was first described by Steere et al. in 1977 who reported an epidemic of arthritis in Lyme, Old Lyme and East Haddam, Conn. In 1982, Dr. Willy Burgdorfer discovered a new spirochete in the midgut of Ixodes dammini ticks (see Burgdorfer, W. A. et al., (1982) Science 216: 1317-1319). This spirochete was subsequently shown to elicit an immune response in infected rabbits which paralleled that in humans with Lyme disease, and is now known to be the etiological agent of the disease. The spirochete was subsequently named Borrelia burgdorferi. [0002] While Ixodes ticks are the most commonly encountered vectors of Borrelia burgdorferi, the spirochetes have also been found in deerflies, horseflies and mosquitoes. Spirochetes enter an animal host when the animal is bitten by the vector. The B. burgdorferi spirochetes reside in various tissues of the host animal, where they may lead to long term infection. [0003]Borrelia burgdorferi have recently...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/02A61P31/04A61K39/00C07K14/20
CPCA61K39/00A61K39/0225A61K2039/521Y10S424/828C07K14/20Y10S514/825A61K2039/55505A61P31/04A61P37/04Y02A50/30
Inventor KORSHUS, JON B.RUNNELS, PAUL L.SHARPEE, RICHARD L.SCHELL, RONALD F.CALLISTER, STEVEN M.
Owner SCHERING CORP
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