86 results about "Mycobacterial antigen" patented technology

The present invention relates to fusion proteins of Mycobacterium tuberclosis antigens. In particular, it relates to two fusion proteins, each of which contains three individual M. tuberculosis antigens, and a fusion protein of two M. tuberculosis antigens, their coding sequences, and methods for their use in the treatment and prevention of tuberculosis.

An assay method and kit is disclosed for detecting the presence of at least one predesignated, target antibody to a mycobacterium in a sample selected from one or more patient bodily fluids. The method comprises the following steps: (a) contacting the sample of one or more patient bodily fluids with at least one mycobacterium antigen on a lateral-flow assay membrane to bind to the target antibody in the sample; (b) previously, simultaneously or subsequently to step (a), binding the at least one mycobacterium antigen with a conjugated label producing a detectable signal; and (c) detecting the signal whereby the presence of the target antibody is determined in the sample by the intensity or presence of the signal. The method can further comprise the step of evaluating immunization status of the patient from whom the sample came by comparing the signal or lack thereof with immunizations previously received by the patient and in comparison to a known standard control. In a preferred embodiment, the mycobacterium antigen specifically binds to Mycobacterium tuberculosis specific antibodies. Preferably, the immunoassay of the present invention comprises a lateral-flow assay comprising a membrane, a conjugated label pad, and at least one mycobacterium antigen bound to the membrane. In a preferred embodiment, the at least one mycobacterium antigen is selected from the group consisting of 38 kDa and 16 kDa antigens.

A method for detection of mycobacterium tuberculosis antigens in biological fluids provides immunoassay methods, diagnostic kits, and an immunochromatoraphic assay device for detection of Mycobacterium tuberculosis antigens in biological specimens, preferably body fluids and tissues. The preferred body fluids are blood, serum, plasma, urine, pulmonary fluid, sputum, cerebrospinal fluid, and the preferred tissue is the lung biopsy specimen. The immunoassays require two primary antibodies against RD1, RD2, or RD3 of Mycobacterium tuberculosis. At least one of the primary antibodies is attached to a solid carrier. Optional, a second antibody against an animal species producing one of the primary antibodies can be added. Either the other primary antibody or the secondary antibody is labeled with a detection agent, which can be an enzymatic marker, a fluorescent or luminescent agent, a radio active label or a color particle. The biological specimens may be used directly, concentrated or diluted for the immunoassays.

The present invention relates to fusion proteins containing at least two Mycobacterium tuberculosis antigens. In particular, it relates to bi-fusion proteins which contain two individual M. tuberculosis antigens, tri-fusion proteins which contain three M. tuberculosis antigens, tetra-fusion proteins which contain four M. tuberculosis antigens, and penta-fusion proteins which contain five M. tuberculosis antigens, and methods for their use in the diagnosis, treatment and prevention of tuberculosis infection.

Systems, methods, and compositions for a diagnostic method for detecting TB in non-human primates that is easy to use, sensitive, and specific. The method utilizes recombinant mycobacterial antigens, such as polyfusion proteins. The method utilizes an antigen-antibody-antigen arrangement to detect TB infection in nonhuman primates. The method can detect IgM antibodies to TB, in addition to IgG antibodies, providing ability to detect TB earlier in nonhuman primate TB infection as compared to conventional TB tests.

Immunogenic compositions comprising an M72 related antigen, wherein the conductivity of the composition is 13 mS/cm or lower, or the concentration of salts of the composition is 130 mM or lower, and their use in medicine, are provided.

The present invention is based on the identification and characterization of a number of novel M. tuberculosis derived proteins and protein fragments. The invention is directed to the polypeptides and immunologically active fragments thereof, the genes encoding them, immunological compositions such as diagnostic reagents containing the polypeptides.

The invention is related to an immunogenic composition, vaccine or pharmaceutical composition for preventing, boosting or treating infection caused by a species of the tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti). The immunogenic composition, vaccine or pharmaceutical composition comprise a fusion polypeptide, which comprises one or more starvation antigens from M. tuberculosis, the units of the fusion polypeptide being M. tuberculosis antigens. Further, the invention is related to the use of a vaccine comprising a fusion polypeptide sequence or nucleic acid sequence of the invention given at the same time as BCG, either mixed with BCG or administered separately at different sites or routes for preparing said immunogenic composition, vaccine, or pharmaceutical composition.

The present invention relates to applications of Mycobacterium tuberculosis antigen protein Rv0446c and a T-cell epitope peptide thereof in preparation of tuberculosis detection reagents, vaccines and medicines, wherein the amino acid sequences of the antigen protein Rv0446c and the T-cell epitope peptide thereof are respectively represented by SEQ ID NO:1-5. According to the present invention, the Mycobacterium tuberculosis antigen protein Rv0446c and the T-cell epitope peptide thereof are used as the stimulants for the specific T cell and B cell immune response caused by Mycobacterium tuberculosis infection, and the false positive caused by the impure antigen can be reduced compared with the use of the complete antigen in the prior art; and the detection reagents prepared from the antigen protein Rv0446c and the T-cell epitope peptide thereof can be widely used for assisted diagnosis of tuberculosis, epidemiological surveillance and other related fields, and the tuberculosis vaccines and the anti-tuberculosis drugs prepared from the antigen protein Rv0446c and the T-cell epitope peptide thereof can be used for prevention and treatment of tuberculosis.

The invention provides a combined antigen comprising three mycobacterium tuberculosis antigens and an application of the combined antigen to preparation of a reagent for diagnosing active tuberculosis. The combined antigen comprises Rv3871, Rv3876 and Rv3879. Corresponding antibody detection methods are established by the aid of the three antigens and used for detecting corresponding antibody levels in biological samples, and the three detected antibody levels are particularly higher in sputum smear negative/sputum culture positive tuberculosis patients. A pulmonary tuberculosis diagnosing method is established by the aid of the combined antigen, and a positive sample is defined in such a manner that antibody levels corresponding to two or more antigens reach a positive judgment value. Verification of a lot of clinical samples indicates that the diagnosing method has the high sensitivity and the high specificity for sputum smear positive/sputum culture positive, sputum smear negative/sputum culture positive and sputum smear negative/sputum culture negative tuberculosis patients.

The present invention relates generally to novel immunogenic combinations comprising or encoding at least two heterooligomeric mycobacterial antigens and preferably a fusion polypeptide comprising said two heterooligomeric mycobacterial antigens, where the mycobacterial antigens are selected from the group of Esx, PE and PPE antigens of a Mycobacterium species, particularly a Mycobacterium of the tuberculosis complex such as Mycobacterium tuberculosis (Mtb). The present invention also relates to vectors, host cells and compositions comprising or encoding said immunogenic combination as well as to methods for expressing and producing it. The present invention also relates to methods of using said immunogenic combination, fusion polypeptide, vector, host cell, composition particularly for inducing or stimulating an immune response with the goal of providing a protective response against a Mycobacterium infection or any disease caused by or associated with a Mycobacterium infection.

The invention relates to one or more types of recombinant fusion proteins formed by hepatitis B core proteins and mycobacterium tuberculosis antigens or antigen fragments. The tuberculosis antigens or antigen fragments are inserted in the same or different permission sites of hepatitis B core proteins in a mode of single antigen or antigen fragment or various types of antigens or antigen fragments which are combined together. The recombinant fusion proteins may comprise a plurality of cofactors. In addition, the invention also relates to the type of the fusion of the tuberculosis antigen or antigen fragments and cofactors and hepatitis B core proteins, nucleic acid and amino acid sequences of coded corresponding recombinant fusion proteins, a method for preparing the recombinant fusion proteins and application of the recombinant fusion proteins in the preparation of medicaments and vaccines for preventing and/or treating tuberculosis.

The present invention relates to a pharmaceutical vaccine composition comprising: (a) a pathogen-derived antigen selected from the group consisting of Mycobacterium tuberculosis antigen, Bacillus anthracis antigen, HAV (hepatitis A virus) antigen, HBV (hepatitis B virus) antigen, HCV (hepatitis C virus) antigen, HIV (human immunodeficiency virus) antigen, influenza virus antigen, HSV (herpes simplex virus) antigen, Hib (Haemophilus influenzae type b) antigen, Neisseria meningitidis antigen, Corynebacterium diphtheriae antigen, Bordetella pertussis antigen, Clostridium tetani antigen and Varicella virus antigen; (b) a deacylated non-toxic LOS (lipooligosaccharide); and (c) a pharmaceutically acceptable carrier.

The invention relates to the identification of mycobacterial antigens which are highly immunogenic and which may be used in assays and methods for the diagnosis of tuberculosis and the discrimination between infected animals and animals previously exposed to vaccines.

The invention provides a recombinant DNA (Deoxyribonucleic Acid) which codes a recombinant antigen of mycobacterium tuberculosis, an expression carrier containing the recombinant DNA, the recombinant antigen of mycobacterium tuberculosis which is coded by the recombinant DNA as well as preparation method and use of the recombinant DNA and the recombinant antigen. The invention further provides a reagent, a composition and a kit containing the recombinant antigen, which can specifically detect infection of mycobacterium tuberculosis. The method is free from cross reaction and can be used for detecting an antigen-specific serum IgG (immunoglobulin G) antibody of the mycobacterium tuberculosis, thereby providing an immunodetection method which is convenient and high in sensitivity, accuracy and stability for development of other kits. The method is simple in using instruments, and the technical operation is relatively easy to master.