Organic compounds -- part of the class 532-570 series – Organic compounds – Carbohydrates or derivatives
Patent
1993-10-26
1998-07-07
Elliott, George G.
Organic compounds -- part of the class 532-570 series
Organic compounds
Carbohydrates or derivatives
536 221, 536 231, 536 241, 536 243, 536 2431, 536 2432, 536 2433, 435 6, 435 912, 4353201, C07H 2102, C07H 2104, C12Q 168, C12P 1934
Patent
active
057770956
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to valuable and useful developments in diagnostics of and vaccines against Borrelia burgdorferi based upon new findings about new classes of Borrelia burgdorferi (from now on B. burgdorferi) and especially about DNA and peptide sequences from the B. burgdorferi strains ACA1 and Ip90 (the same as Iper90) and their relationship to B. burgdorferi strain B31, including special sequences from the three different strains of B. burgdorferi useful as primers in the PCR-DNA detection of B. burgdorferi in specimens from animals, including humans, a diagnostic kit for diagnosing Lyme disease in animals, including humans, DNA sequences from B. burgdorferi strains ACA1 and Ip90 encoding polypeptides related to the outer membrane protein OspA and OspB, a polypeptide encoded from ACA1 and Ip90, epitopes from OspA and OspB, and a vaccine against Lyme disease comprising one or more epitopes from OspA and OspB.
BACKGROUND OF THE INVENTION
Lyme disease is a zoonosis caused by the tick-borne spirochaete B. burgdorferi. When a susceptible host is bitten by an ixodid tick, B. burgdorferi organisms enter the skin. In humans the initial skin manifestation is termed erythema chronicum migrans (ECM) whereas a long-standing infection of the skin produces acrodermatitis chronica atrophicans. The Borrelia organisms also enter the circulatory system of the host and are distributed to various organs, including the brain and joints. A secondary spread of the pathogens produces a variety of clinical syndromes, including lymphocytic meningoradiculitis, myocarditis and chronic arthritis. In many patients the infection of some tissues, particularly the brain and joints, persists for years and can be severely disabling. These forms of chronic Lyme disease are a consequence of the host's inability to rid itself of the infectious agent and perhaps the development of an autoimmune reaction.
Diagnosis of Lyme disease has chiefly been based on clinical evidence. The best marker during the primary stage of infection has conventionally been the presence of erythema chronicum migrans (ECM) but these skin lesions may not always develop or they may manifest atypically. Moreover, Lyme disease can be confused with other illnesses characterized by neurologic or arthritic manifestations. When clinical histories are incomplete, serologic testing with determination of antibody titers is the best conventionally laboratory method of diagnosis. Indirect fluorescent antibody (IFC) staining tests and enzyme-linked immunosorbent assays (ELISA) are used to detect total immunoglobulins or class-specific IgM and IgG antibodies to B. burgdorferi. ELISA is usually preferred because the procedures are more easily standardized and automated and because absorbance values can be statistically analyzed to give more objective results.
B. burgdorferi spirochaetes are helically shaped, motile cells with an outer cell membrane that surrounds a protoplasmic cylinder complex, consisting of the cytoplasm, the cell wall, the inner cell membrane and the flagella which are located not at the cell surface but in the periplasmic space between the outer cell membrane and the protoplasmic cylinder. The outer cell membrane and the flagella are assumed to play an important role in the host-parasite interactions during the disease and has been subjected to several investigations, identifying major surface-exposed proteins as important immunogens.
It has been shown that the earliest IgM antibodies formed against antigens of the B. burgdorferi strain B31, which was deposited in the American Type Culture Collection in 1983 with the accession number ATCC 35210, are directed against a genus-specific flagellar polypeptide termed flagellin having a molecular weight of 41 kd (18) and which reacts with monoclonal antibody H9724. IgG antibodies are also first directed to the 41 kd flagellin, but with advancing disease IgG antibodies form against other immunogens, especially against two abundant proteins with molecular weights of 31 kd and 34 kd. These two proteins, wh
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Barbour Alan George
Bergstrom Sven
Hansson Lennart
Elliott George G.
Fredman Jeffrey
Kowalski Thomas J.
Symbicom Aktiebolag
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