Antigens for Detection of Early Lyme Disease
AssigneesAntigen Discovery, Inc., Academisch Medisch Centrum
InventorsJoppe Willem Robert Hovius, Abhijeet Nayak, Arlo Randall, Gary Hermanson, Angela Yee
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Abstract
Selected Antigens for early detection of Lyme disease are presented, and particularly for Lyme disease caused by B. afzelii. Advantageously, these antigens allow for unprecedented and unexpectedly high sensitivity and specificity in detection of early Lyme disease.
Claims55
A test kit for detection of early Lyme disease, comprising a carrier coupled to an early-stage antigen of B. afzelii, wherein the antigen has at least 90% identity to a protein sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:4, and SEQ ID NO:
- 6, or an antigenic fragment thereof.
The test kit of any one of the preceding claims, further comprising an additional antigen of B. afzelii, wherein the additional antigen is selected form the group consisting of FlaB, P83/100, DbpA, DbpB, P66, VlsE, and OspC, or an antigenic fragment thereof.
An antigen composition, comprising:
- an early-stage antigen of B. afzelii, wherein the antigen has at least 90% identity to a protein sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:
- 4, and SEQ ID NO:6, or an antigenic fragment thereof;
- and
- optionally an additional antigen of B. afzelii, wherein the additional antigen is selected form the group consisting of FlaB, P83/100, DbpA, DbpB, P66, VlsE, and OspC, or an antigenic fragment thereof.
An antigen of B. afzelii for use in detection of early Lyme disease and/or infection of a subject with B. afzelii, wherein the antigen has at least 90% identity to a protein sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:4, and SEQ ID NO:6, or an antigenic fragment thereof.
A method of detecting early Lyme disease and/or an early stage of infection of a subject with B. afzelii, comprising:
- contacting in vitro an antigen of B. afzelii with a blood sample of the subject;
- wherein the antigen has at least 90% identity to a protein sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:4, and SEQ ID NO:6, or an antigenic fragment thereof;
- and
- detecting binding of an antibody in the blood sample to the antigen.
A method of manufacturing a component for a test kit for detection of early-stage infection of a subject with B. afzelii or early disease of a subject, comprising:
- providing a nucleic acid or fragment thereof having at least 90% identity to a nucleic acid sequence selected from the group consisting of SEQ ID NO:1, SEQ ID NO:
- 3, and SEQ ID NO:5;
- recombinantly expressing the nucleic acid sequence or fragment thereof to thereby produce a recombinant protein that binds to an early-stage antigen of B. afzelii;
- and
- including the recombinant protein into a test kit for detection of early-stage infection of a subject with B. afzelii.
A vaccine composition, comprising:
- a pharmaceutically acceptable carrier in combination with at least one antigen of B. afzelii or a nucleic acid encoding the antigen;
- wherein the antigen has at least 90% identity to an amino acid sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:4, and SEQ ID NO:6, or an antigenic fragment thereof;
- and
- wherein the nucleic acid has at least 90% identity to a nucleic acid sequence selected from the group consisting of SEQ ID NO:1, SEQ ID NO:3, and SEQ ID NO:5, or portion thereof, wherein the portion encodes an antigenic fragment of SEQ ID NO:
- 2, SEQ ID NO:4, or SEQ ID NO:6, or wherein the nucleic acid is an RNA transcript of the nucleic acid sequence or portion thereof.
A nucleic acid encoding an antigen of B. afzelii for use in preparation of a vaccine, wherein the nucleic acid has at least 90% identity to a nucleic acid sequence selected from the group consisting of SEQ ID NO:1, SEQ ID NO:3, and SEQ ID NO:5, or an antigenic fragment thereof.
Dependencies are inferred from the claim text.