Abstract: A bioadhesive mucosal delivery system is used in concert with systemic immunization to develop long-lasting immune responses correlative to protective immunity, especially for the prevention of infection with malaria, tularemia, anthrax, and H. pylori. First, the method provides controlled delivery of protective antigens, such as ODNs, to a mucosal site resulting in “priming” of mucosal receptors. Second, the method augments this mucosal prime with parenteral stimulation. In another embodiment, an intranasal vaccine is used in the treatment of tularemia and other bacterial and viral inhalation antigens. The use of CpG motifs in bacterial DNA allows for the activation of the innate immune response that is characterized by the production of immunostimulatory cytokines and polyreactive antibodies. The rapid response system limits the spread of the pathogen prior to specific immunity activation.

Abstract: The invention provides a DNA molecule comprising a promoter sequence operably linked to a DNA sequence encoding first and second proteins linked by a hinge region wherein in that the promoter sequence can be one having activity which is induced in response to a change in the surrounding environment and the first protein can be Tetanus toxin C fragment or one or more epitopes thereof. The invention also provides intermediate molecules having a promoter operably linked to a DNA sequence encoding a first antigenic sequence and a hinge region, and at or adjacent the 3′-end thereof one or more restriction sites for the introduction of a second anti-genic sequence. In addition, the invention provides replicable expression vectors containing the DNA fusion proteins expressed therefrom, bacterial transformed with the vectors and the use of the bacteria, in vaccines.

Abstract: The present invention relates to hydrophilic Eimeria polypeptides, DNA-fragments encoding those peptides, recombinant DNA molecules comprising such DNA-fragments, live recombinant carriers comprising such DNA-fragments or recombinant DNA molecules and host cells comprising such DNA-fragments, recombinant DNA molecules or live recombinant carriers. Furthermore, the invention relates to antibodies against the polypeptides and to coccidiosis vaccines based upon said polypeptides. The invention also relates to methods for the preparation of such antibodies and vaccines, and to methods for the detection of Eimeria parasites and antibodies against Eimeria parasites.

Abstract: Vaccine compositions comprising peroxiredoxin and/or &bgr;-tubulin antigenic material, preferably of Fasciola or Dicrocoelium origin, for use in combating a parasitic infestation of helminths in a mammal, are provided. Also provided are nucleic acid sequences which encode peroxiredoxin and/or &bgr;-tubulin molecules and the amino acid sequences thereof, vectors comprising said nucleic acid sequences and cells transformed with such vectors.

Abstract: In this application is described the expression and purification of a recombinant Plasmodium falciparum (FVO) MSP-142. The method of the present invention produces a highly purified protein that retains folding and disulfide bridging of the native molecule. The recombinant MSP-142 is useful as a diagnostic reagent, for use in antibody production, and as a vaccine.

Abstract: Polypeptides comprising amino acid sequences of particulate antigens isolated from various species of Leishmania protozoa, or immunogenic variants thereof, are disclosed for the treatment and clinical remission of psoriasis. Also disclosed are nucleic acid sequences encoding such polypeptides, vectors incorporating such nucleic acid sequences, methods for genetically engineering microbial host cells to produce such polypeptides, and such recombinant microbial host cells. In another embodiment, immunotherapeutic agents incorporating the polypeptides or the nucleic acid sequences are disclosed for the treatment and clinical remission of psoriasis. In another embodiment, methods for the production of the polypeptides using recombinant microbial host cells are disclosed. Finally, methods for the treatment and clinical remission of psoriasis comprising administration of a pharmaceutical composition comprising one or more of the polypeptides or one or more of the nucleic acid sequences are disclosed.

Abstract: Embodiments of the invention generally provide methods and compositions for producing disease-specific antigens. In one aspect, the invention provides a method of producing an antigen specific for Alzheimer's disease. In another aspect, the invention provides a method of producing a polyvalent antigen for two or more diseases. In yet another aspect, compositions of antigens are prepared and provided to immunize animals and induce strong immune responses.

Abstract: The invention relates to an anti-inflammatory oligopeptide which can be obtained from the microorganism Entamoeba histolytica or synthesized by known methods. The oligopeptides are useful in treating inflammatory diseases when formulated in pharmaceutical compositions for administration to patients.

Abstract: The present invention provides methods and compositions for eliciting protective immunity against malaria. In particular, the invention relates to universal T-cell epitopes that elicit T-cell responses in individuals of differing genetic backgrounds. Immunogenic compositions and vaccines including malaria-specific universal T-cell epitopes are disclosed.

Abstract: The present invention provides novel vaccines, methods for the production of such vaccines and methods of using such vaccines. The novel vaccines of the present invention combine both of the signals necessary to activate native T-cells—a specific antigen and the co-stimulatory signal—leading to a robust and specific T-cell immune response.

Abstract: The present invention is directed to the cloning, sequencing and expression of homologous immunoreactive 28-kDa protein genes, p28-1, -2, -3, -5, -6, -7, -9, from a polymorphic multiple gene family of Ehrlichia canis. Further disclosed is a multigene locus encoding all nine homologous 28-kDa protein genes of Ehrlichia canis. Recombinant Ehrlichia canis 28-kDa proteins react with convalescent phase antiserum from an E. canis-infected dog, and may be useful in the development of vaccines and serodiagnostics that are particularly effective for disease prevention and serodiagnosis.

Abstract: The present invention provides compositions and methods of use of urea amidohydrolase (Ure) antigens and polynucleotides encoding the Ure antigens for generating an immunological response in an individual and in therapeutic and diagnostic applications of infections due to pathogenic Coccidioides spp. fungi, such as C. immitis or C. posadasii.

Abstract: In this application is described the expression cloning and functional characterization of the CD36-binding domain of Sequestrin. Sequestrin is a surface protein of 215-250 kD size which does not vary in size between parasite strains. The Sequestrin gene appears to be single-copy-number within the genome; noncytoadherent laboratory parasite strains carry the sequestrin gene but fail to express the protein. Sequestrin binds with high affinity to CD36. Sequestrin protein and sequence can be used as a diagnostic, prognostic, and therapeutic tool.

Abstract: The invention relates to a method for enhancing the specific immune response against an immunogenic compound which comprises administering the immunogenic compound together with a poxvirus recombinant and a vaccinal antigen, which is not a poxvirus. The immunological material may be any biological material useful as a vaccine e.g., a polypeptide characteristic of a pathogenic microorganism or associated with a tumoral disorder, a DNA plasmid encoding a peptide or a polypeptide characteristic of a pathogenic microorganism or a tumor-associated antigen, or an hapten coupled to a carrier molecule. The poxvirus may be a live, attenuated or inactivated virus or a recombinant virus. Recombinant virus may encode a heterologous polypeptide such as chemokines, cytokines or co-immunostimulatory molecules or an homologous polypeptide, which is immunologically cross reactive with the immunogenic polypeptide or peptide.

Abstract: Compositions and methods for preventing, treating and detecting leishmaniasis and stimulating immune responses in patients are disclosed. The compounds provided include polypeptides that contain at least an immunogenic portion of one or more Leishmania antigens, or a variant thereof. Vaccines and pharmaceutical compositions comprising such polypeptides, or polynucleotides encoding such polypeptides, are also provided and may be used, for example, for the prevention and therapy of leishmaniasis, as well as for the detection of Leishmania infection.

Abstract: A method of treating chronic hepatitis B is disclosed that comprises administering a T cell-stimulating amount of a vaccine to a patient. The vaccine comprises an immunogenic amount of chimeric, carboxy-terminal truncated hepatitis B virus nucleocapsid (core) protein (HBc) that is engineered for both enhanced stability of self-assembled particles and the substantial absence of nucleic acid binding by those particles. The chimeric protein molecule can include one or more immunogenic epitopes peptide-bonded to one or more of the N-terminus, the immunogenic loop or the C-terminus of HBc. The enhanced stability of self-assembled particles is obtained by the presence of at least one heterologous cysteine residue near one or both of the amino-terminus and carboxy-terminus of the chimer molecule.

Abstract: The present invention relates to a novel Neospora caninum isolate from Nowra and extracts thereof. The strain is useful in the development of diagnostic assays for the detection of parasites in animals. The present invention also relates to pharmaceutical compositions, using live or killed organisms or extracts thereof, for the treatment and prevention of parasitic infections in animals.

Abstract: A chimeric, carboxy-terminal truncated hepatitis B virus nucleocapsid protein (HBc) is disclosed that is engineered for both enhanced stability of self-assembled particles and the display of an immunogenic epitope. The immunogenic epitope is peptide-bonded to one or more of the N-terminus, in the immunogenic loop or at the C-terminus of HBc, whereas the enhanced stability of self-assembled particles is obtained by the presence of at least one heterologous cysteine residue near the aminio-terminus of the chimer molecule. Methods of making and using the chimers are also disclosed.

Abstract: A transcriptional activator of T. gondii is provided which comprises the tetracycline repressor (TetR) operatively linked to a transacting factor of T. gondii. Strains of T. gondii transformed with a vector containing such a transactivator may be used to prepare vaccine compositions or to identify essential genes in the parasite. The system provided may be useful in other Apicomplexan species such as Plasmodium falciparum, Plasmodium vivax, Plasmodium berghei, Plasmodium yoelii, Plasmodium knowlesi, Trypanosoma brucei, Entamoeba histolytica, and Giardia lambia.

Abstract: Methods for improving binding of a proteinaceous substance to cell-wall material of a Gram-positive bacterium are disclosed. The proteinaceous substance includes an AcmA cell-wall binding domain, homolog or functional derivative thereof. The method includes treating the cell-wall material with a solution capable of removing a cell-wall component such as a protein, lipoteichoic acid or carbohydrate from the cell-wall material and contacting the proteinaceous substance with the cell-wall material.

Abstract: Thiol proteases having Cathepsin 1 type activity are used in the formulation of vaccines for combating helminth parasites. Preferably the protease is derived from a fluke such as Fasciola hepatica.

Abstract: The present invention provides a recombinant nucleic acid molecule encoding a fusion polypeptide, wherein the recombinant nucleic acid comprises a heterologous polynucleotide sequence encoding an antigen or an antigenic fragment, and a Leishmania polynucleotide sequence encoding a polypeptide or fragment thereof, wherein the Leishmania polynucleotide is selected from the group consisting of TSA polynucleotide, LeIF polynucleotide, M15 polynucleotide, and 6H polynucleotide. The invention also provides an expression cassette comprising the recombinant nucleic acid molecule, host cells comprising the expression cassette, compositions, fusion polypeptides, and methods of their use in diagnosis or in generating a protective immune response in hosts.

Abstract: The present invention relates to nucleic acid sequences encoding novel Babesia canis associated proteins and to cDNA fragments, recombinant DNA molecules and live recombinant carriers comprising these sequences. Furthermore, the invention relates to host cells comprising such nucleic acid sequences, cDNA fragments, recombinant DNA molecules and live recombinant carriers. Also, the invention relates to proteins encoded by these nucleotide sequences, to vaccines for combating Babesia canis infections comprising these proteins or genetic material encoding these proteins and methods for the preparation of vaccines. Another embodiment of the invention relates to these Babesia canis associated proteins for use in vaccines and to the use of the Babesia canis associated proteins in the manufacture of vaccines.

Abstract: The present invention relates to the immunization of animals and humans with trypanosome tubulin to protect against trypanosomes. More particularly, the present invention relates to a substantially pure tubulin preparation, which comprises a tubulin extract from Trypanosoma brucei which tubulin preparation can protect animals and humans against heterologous strains of different species of Trypanosoma.

Abstract: Compositions and methods for preventing, treating and detecting leishmaniasis and stimulating immune responses in patients are disclosed. The compounds provided include polypeptides that contain at least an immunogenic portion of one or more Leishmania antigens, or a variant thereof. Vaccines and pharmaceutical compositions comprising such polypeptides, or polynucleotides encoding such polypeptides, are also provided and may be used, for example, for the prevention and therapy of leishmaniasis, as well as for the detection of Leishmania infection.

Abstract: In this application is the expression and purification of a recombinant Plasmodium falciparum (3D7) MSP-142. The method of the present invention produces a highly purified protein which retains folding and disulfide bridging of the native molecule. The recombinant MSP-142 is useful as a diagnostic reagent, for use in antibody production, and as a vaccine.

Abstract: The invention provides novel preparations for a broad-spectrum antiplasmodial vaccine.

Abstract: In this application is the expression and purification of a recombinant Plasmodium falciparum (3D7) MSP-142. The method of the present invention produces a highly purified protein which retains folding and disulfide bridging of the native molecule. The recombinant MSP-142 is useful as a diagnostic reagent, for use in antibody production, and as a vaccine.

Abstract: The present invention provides liposomal vaccines containing immunogenic lipopeptides that are capable of modulating the humoral and cellular immune responses in vivo.

Abstract: A composition and method for stimulating an immune response against an antigen in immunised individuals or in cell groups.

Abstract: In this application is the expression and purification of a recombinant Plasmodium vivax (SalI) PvMSP-1 p42. The method of the present invention produces a highly purified protein which retains folding and disulfide bridging of the native molecule. The recombinant PvMSP-1 p42 is useful as a diagnostic reagent, for use in antibody production, and as a vaccine.

Abstract: Compositions and methods for preventing, treating and detecting leishmaniasis and stimulating immune responses in patients are disclosed. The compounds provided include polypeptides that contain at least an immunogenic portion of one or more Leishmania antigens, or a variant thereof. Vaccines and pharmaceutical compositions comprising such polypeptides, or polynucleotides encoding such polypeptides, are also provided and may be used, for example, for the prevention and therapy of leishmaniasis, as well as for the detection of Leishmania infection.

Abstract: In this application is described the expression and purification of a recombinant Plasmodium falciparum (3D7) AMA-1 ectodomain. The method of the present invention produces a highly purified protein which retains folding and disulfide bridging of the native molecule. The recombinant AMA-1 is useful as a diagnostic reagent, for use in antibody production, and as a protein for use alone, or as part of, a vaccine to prevent malaria.

Abstract: Chimeric gene formed by the DNA sequences that encode the antigenic determinants of four proteins of L. infantum, useful for the serological diagnosis of canine Leishmaniosis and protein obtained, that consists of the prior employment of a cloning strategy. The patent describes the intermediate products generated during the process. A clone is achieved expressed in the protein rLiPO-Ct-Q (pPQI). To this initial vector, by means of the use of suitable restriction targets, DNA fragments are sequentially added that are encoded in other proteins and after each cloning step the correct orientation of each one of the inserts reduces the size of the expression products, the complete nucleotide sequence of the final pPQV clone being determined. A polypeptide is obtained with a molecular mass of 38 kD and with an isoelectric point of 7.37.

Abstract: A vaccine composition useful in the prevention or treatment of malaria comprises a plurality of malaria-derived antigens in combination with an adjuvant which is a preferential stimulator of TH1 cell response,

Abstract: Novel combined vaccine composition preferentially for administration to adolescents are provided, comprising a hepatitis B viral antigen and a herpes simplex viral antigen and optionally in addition one or more of the following: an EBV antigen, a hepatitis A antigen or inactivated attenuated virus, an HPV antigen, a V2V antigen, a HCMV antigen, a Toxoplasma gondii antigen. The vaccine compositions are formulated with an adjuvant which is a preferential stimulator of TH1 cell response such as 3D-MPL and QS21.

Abstract: The present invention relates to a vaccine against malaria comprising a polypeptide having the amino acid sequence of the C-terminal part of the circumsporozoite protein of a Plasmodium species, in which polypeptide one or more pairs of cysteine residues are oxidized, and optionally a suitable carrier and/or adjuvant and/or biodegradable microcapsules for use in humans.

Abstract: Vaccines, antibodies, polypeptides, DNAs and RNAs for diagnosis, prophylaxis, treatment and detection of malaria or Plasmodium infection. P. falciparum antigen and fragments thereof and recombinant proteins or fusion proteins produced thereby. Methods for diagnosis, prophylaxis, treatment and detection of malaria or Plasmodium infection.

Abstract: Compositions and methods are provided for the induction of a protective immunize response in primates against a lethal challenge of Plasmodium.

Abstract: Compounds and methods for the diagnosis and treatment of B. microti infection are disclosed. The compounds provided include polypeptides that contain at least one antigenic portion of a B. microti antigen and DNA sequences encoding such polypeptides. Antigenic epitopes of such antigens are also provided, together with pharmaceutical compositions and vaccines comprising such polypeptides, DNA sequences or antigenic epitopes. Diagnostic kits containing such polypeptides, DNA sequences or antigenic epitopes and a suitable detection reagent may be used for the detection of B. microti infection in patients and biological samples. Antibodies directed against such polypeptides and antigenic epitopes are also provided.

Abstract: The present invention provides novel enzymes, tryparedoxins, their isolation from Crithidia fasciculata, a method for the production thereof in genetically transformed bacteria, and their use as molecular targets for the discovery of trypanocidal drugs

Abstract: The invention relates to an ex vivo animal or challenge model as a method to identify protective (recombinant) proteins and rapidly measure protective immunity in intestinal segments directed against parasites and vaccines directed against parasitic infections. The invention further relates to vaccines directed against infection with parasites, such as Fasciola hepatica, which vaccines contain protective (recombinant) proteins identified and shown to be protective in studies using the ex vivo model. The invention further relates to protective (recombinant) proteins obtained from newly excysted juveniles (NEJ) of Fasciola hepatica. The protective (recombinant) protein corresponding to an NEJ protein has an apparent molecular weight of 32 kDa and an N-terminal amino acid sequence comprising the sequence XXDVSWPFWDRMYNY (SEQ ID NO:1).

Abstract: Diagnostic tools for for serodiagnosing ehrlichiosis in mammals, particularly in members of the Canidae family and in humans are provided. The diagnostic tools are a group of outer membrane proteins of E. chaffeensis and variants thereof, referred to hereinafter as the “OMP proteins”, a group of outer membrane proteins of E. canis and variants thereof referred to hereinafter as the “P30F, proteins”, and antibodies to the OMP proteins and the P30F proteins. The OMP proteins of E. chaffeensis encompass OMP-1, OMP-1A, OMP1-B, OMP-1C, OMP1-D, OMP1-E, OMP1-F, OMP1-H, OMP-1R, OMP-1S, OMP-1T, OMP-1U, OMP-1V, OMP-1W, OMP-1X, OMP-1Y and OMP-1Z. The P3OF proteins of E. canis encompass P30, P30a, P30-1, P30-2, P30-3, P30-4, P30-5, P30-6, P30-7, P30-8, P30-9, P30-10, P30-11, and P30-12. Isolated polynucleotides that encode the E. chaffeensis OMP proteins and isolated polynucleotides that encode the E. canis P30F protein are also provided.

Abstract: The invention discloses a molecule or polypeptide composition characterized by the presence in its structure of one or more peptide sequences bearing all or part of one or more T epitopes, and possibly other epitopes, particularly B epitopes, charactistic of proteins resulting from the infectious activity of P. falciparum in hepatic cells. Also disclosed is the use of these molecules in tests, and a set or kits for in vitro diagnosis of paludism from a biological sample from the individual in whom the disease is to be detected. The use of these molecules in compositions for paludism vaccines is also covered.

Abstract: The present invention relates to the use of the major OprI lipoprotein of Pseudomonas aeruginosa to elicit a Type-1 immune response towards a heterologous antigen. The invention relates specifically to the use of OprI—antigen fusion proteins to elicit the Type-1 response. More particularly, the present invention is directed to pharmaceutical formulations comprising OprI and/or OprI fusion proteins, optionally together with a suitable excipient, to stimulate the Th1 dependent, cellular immune response.

Abstract: Attenuated recombinant viruses containing DNA coding for a cytokine and/or a tumor associated antigen, as well as methods and compositions employing the viruses, are disclosed and claimed. The recombinant viruses can be NYVAC or ALVAC recombinant viruses. The DNA can code for at least on of: human tumor necrosis factor; nuclear phosphoprotein p53, wildtype or mutant; human melanoma-associated antigen; IL-2; IFN&ggr;; IL-4; GNCSF; IL-12; B7; erb-B-2 and carcinoembryonic antigen. The recombinant viruses and gene products therefrom are useful for cancer therapy.

Abstract: A chimeric polypeptide encoded by a chimeric gene formed by DNA sequences that encode four antigenic determinants of L. infantum is disclosed. These antigenic determinants are obtained from rLiP2a, rLiP2b, rLiH2A and rLiPO. The protein obtained, has a molecular mass of 38 KD with an isoelectric point of 7.37. This chimeric polypeptide is useful for diagnosing, preventing and/or treating leishmaniosis in animals or humans.

Abstract: The present invention provides a protein of the following formula (I) having immunomodulatory activity: X-Y-Z (I) wherein X represents an amino acid sequence of SEQ ID NO: 1 or 2, each of Y and Z is absent or represents an amino acid sequence of SEQ ID NO: 1 or 2. The above protein is derived from helminth and can be used to treat various immune diseases due to its immunomodulatory activity. The above protein can also be used to treat various allergic diseases due to is ability to stimulate the production of non-specific IgE.

Abstract: The invention is directed to improved immunopotentiating systems for preparation of immunogenic materials. More particularly, the invention is directed to immunogenic compositions containing a protein, polypeptide, or peptide, a hydrophobic anchor, and a proteosome. The immunogenic compositions are suitable for use as therapeutic agents and vaccines.

Abstract: Disclosed is an in vivo system for the development of CD4+ T cells bearing class II MHC restricted TCR. The cells are induced by the administration of a positively selecting, soluble peptide. Following peptide delivery, double-positive CD4+CD8+ cells expressing this TCR differentiate into CD4+ cells in vivo, or in vitro in thymic organ cultures. This system facilitates the development of antigen-specific functional CD4+ T cells in a controlled manner, after administration of the peptide. The positively selected CD4+ T cells remain in the periphery for a prolonged time and respond to the appropriate antigenic challenge.