Gundersen Lutheran Medical Foundation, Inc.

Intervet Inc.

Qiagen Sciences, LLC

Biopeptides Corporation

Solvay Animal Health, Inc.

Gundersen Medical Foundation, Ltd.

Intervet International B.v.

Steven M Callister

Ronald F Schell

Rhonda LaFleur

Terri L Wasmoen

Raymond Dattwyler

Raymond J Dattwyler

Paul M Arnaboldi

Misato Miyamasu

Steven D Lovrich

Dean A Jobe

Jeff Boyle

Mark A Mogler

Zhichang Xu

Jennifer C Dant

Richard L Sharpee

Paul L Runnels

Jon B Korshus

Rhonda Lafleur

Compositions and methods are provided for detection, diagnosis and prognosis of Lyme disease (LD), including a method for confirmingspp. infection by contacting, in vitro, whole blood samples from subjects suspected of having LD with synthetic peptides comprising T-cell epitope-containing regions derived fromproteins that are expressed at different stages of Lyme disease, and indirectly detecting LD-specific activated T-cells by determining production of a T-cell immune response indicator (e.g., interferon-Y) in response to stimulation by the peptides. Also disclosed are methods for predicting elimination of LD spirochetes in LD patients who have undergone LD treatment, by exposing whole blood samples from such subjects to peptides comprising specific T-cell epitope regions ofproteins that are expressed at different stages of Lyme disease, and confirming a lack of-specific activated T-cells in the samples by the absence of a detectable T-cell immune response indicator (e.g., interferon-Y).

Compositions and methods for diagnosing Lyme disease and for predicting Lyme disease spirochete elimination after treatment

The present invention provides a vaccine for canine Lyme disease and methods of making and using the vaccine alone, or in combinations with other protective agents.

Canine lyme disease vaccine

Canine Lyme disease vaccine

The present invention relates, in one aspect, to the detection of Lyme disease in canines by detecting the peptide or antibodies to an infection specific peptide after challenge with. The 20 kDa peptide is not detectable in human sera samples after challenge or infection withand, as such, appears to be specific for canines and suitable for the consistent detection of Lyme disease in canines at time points earlier that possible with prior art methods.

Early detection of canine lyme disease by specific peptides and antibodies

An OspC Dra fragment fusion peptide isolated from is described herein for the prevention, treatment and early diagnosis of Lyme disease in humans and other animals. This invention also relates to a screening method detecting anti-Osp borreliacidal antibody activity, and antibodies reacting with a protein fragment encoded by a DraI-SmaI DNA fragment of OspC.

Compositions and methods using the borreliacidal epitope(s) of Borrelia burgdorferi outer surface protein C (OspC) for the diagnosis and prevention of lyme disease

A bacterin including effective immunizing amounts of two non-crossprotective isolates of inactivated,, an adjuvant in an amount effective to enhance the immunogenicity of the inactivated,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,isolate and a second, non-crossprotective,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,. Further provided is a bacterin which includes effective immunizing amounts of two non-crossprotective isolates of inactivated,and one or more antigenic subunits from the non-crossprotective isolates, an adjuvant in an amount effective to enhance the immunogenicity of the inactivated,and antigenic subunits and a suitable carrier. Methods of immunizing an animal against,infection which comprise administering to the animal a dose of a bacterin provided herein are also provided.

Borrelia burgdorferi bacterin

An OspC Dra fragment fusion peptide isolated from,is described herein for the prevention, treatment and early diagnosis of Lyme disease in humans and other animals. This invention also relates to a screening method detecting anti-Osp borreliacidal antibody activity, and antibodies reacting with a protein fragment encoded by a DraI-SmaI DNA fragment of OspC.

Compositions and methods using the borreliacidal epitope(s) of borrelia burgdorferi outer surface protein C (OspC) for the diagnosis and prevention of lyme disease

A method of performing an assay to determine whether a patient has been exposed to or infected by Borrelia burgdorferi is disclosed which comprises collecting serum from the patient; preparing a sample mixture comprising a portion of the patient's serum and an inoculum of viable Borrelia burgdorferi organisms; incubating the sample mixture; determining the number of viable organisms remaining in the sample mixture after incubation; and comparing the number with the quantity of viable organisms remaining in a control. An assay kit is also disclosed which is useful for determining whether a patient has been exposed to or infected by Borrelia burgdorferi. The kit contains reagents necessary to practice the assay method disclosed herein. In its broadest form, the kit comprises an inoculum of viable Borrelia burgdorferi organisms. The kit can also contain an aliquot of normal serum, an aliquot of BSK medium and/or an aliquot of complement. Other reagents, tubes and other materials can also be included in the kits.

Diagnostic assay for lyme disease

Growing community of inventors

Onalaska, WI, United States of America

Steven M Callister