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Title:  Compositions and methods comprising DNA sequences encoding B. burgdorferi polypeptides

United States Patent:  6,344,552

Inventors:  Flavell; Richard A. (Killingworth, CT); Kantor; Fred S. (Orange, CT); Barthold; Stephen W. (Madison, CT); Fikrig; Erol (Guilford, CT)

Assignee:  Yale University (New Haven, CT)

Appl. No.:  455973

Filed:  May 31, 1995

Abstract

Methods and compositions for the prevention and diagnosis of Lyme disease. OspA and OspB polypeptides and serotypic variants thereof, which elicit in a treated animal the formation of an immune response which is effective to treat or protect against Lyme disease as caused by infection with Borrelia burgdorferi. Anti-OspA and anti-OspB antibodies that are effective to treat or protect against Lyme disease as caused by infection with B. burgdorferi. A screening method for the selection of those OspA and OspB polypeptides and anti-OspA and anti-OspB antibodies that are useful for the prevention and detection of Lyme disease. Diagnostic kits including OspA and OspB polypeptides or antibodies directed against such polypeptides.

DISCLOSURE OF THE INVENTION

The present invention provides in one preferred embodiment OspA polypeptides and pharmaceutically effective compositions and methods comprising those polypeptides, which are useful for the treatment or prevention of Lyme disease. The preferred compositions and methods of this embodiment are characterized by OspA polypeptides which elicit in a treated patient, the formation of an immune response which is effective to treat or protect against Lyme disease as caused by infection with B. burgdorferi.

In another preferred embodiment, this invention provides OspB polypeptides and pharmaceutically effective compositions and methods comprising those polypeptides, which are useful for the treatment or prevention of Lyme disease. The preferred compositions and methods of this embodiment are characterized by OspB polypeptides which elicit in a treated patient, the formation of an immune response which is effective to treat or protect against Lyme disease as caused by infection with B. burgdorferi.

In yet another embodiment, this invention provides antibodies directed against the OspA or OspB polypeptides of this invention, and pharmaceutically effective compositions and methods comprising those antibodies. The antibodies of this embodiment are those that are immunologically reactive with the OspA or OspB polypeptides of this invention, and are effective to treat or protect against Lyme disease as caused by infection with B. burgdorferi.

This invention further provides a novel screening process, using a specific nonhuman, mammalian model, for selecting the preferred OspA and OspB polypeptides and antibodies of this invention that are effective to protect against Lyme disease. The screening process of this invention comprises the steps of:

1) immunizing a C3H/He mouse with an OspA or OspB polypeptide or antibody of this invention;

2) inoculating the immunized animal with B. burgdorferi; and

3) selecting those OspA or OspB polypeptides or antibodies which are effective to protect the animal against Lyme disease.

In another embodiment, this invention provides diagnostic means and methods characterized by OspA or OspB polypeptides, or antibodies directed against these polypeptides. These means and methods are useful for the detection of Lyme disease and B. burgdorferi infection. They are also useful in following the course of treatment against such infection.

Finally this invention provides DNA sequences that code for the OspA and OspB polypeptides of this invention, recombinant DNA molecules that are characterized by those DNA sequences, unicellular hosts transformed with those DNA sequences and molecules, and methods of using those sequences, molecules and hosts to produce the OspA and OspB polypeptides of this invention.

Claim 1 of 20 Claims

We claim:

1. A recombinant, synthetic or isolated DNA molecule comprising a DNA sequence that encodes a polypeptide, wherein the polypeptide is selected from the group consisting of:

(a) a polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 4;

(b) a polypeptide comprising the amino acid sequence from position 2 to 273 of SEQ ID NO: 4;

(c) a polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 10;

(d) a polypeptide comprising the amino acid sequence from position 2 to 273 of SEQ ID NO: 10;

(e) the polypeptide encoded by nucleotides 200-819 of SEQ ID NO: 3; and

(f) the polypeptide encoded by nucleotides 400-819 of SEQ ID NO: 3.

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If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.

 

 

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