Abstract: The invention relates to methods for the preparation of a pharmaceutical-vesicle formulation comprising steps of: preparing and processing vesicle components and a pharmaceutical agent to entrap the pharmaceutical agent in the vesicle and form a pharmaceutical-vesicle formulation, wherein the pharmaceutical-vesicle formulation is reconstituted in a known quantity of the pharmaceutical agent dissolved in a pharmaceutically-acceptable carrier to provide a biphasic pharmaceutical-vesicle formulation. The invention also relates to the associated pharmaceutical-vesicle formulations, pharmaceutical kits and uses as a medicament, in particular for the prevention or treatment of infection by bacteria such as Burkholderia pseudomallei and Francisella tularensis, and viruses such as Venezuelan Equine Encephalitis Virus (VEEV).

Abstract: The invention relates to methods for the preparation of a pharmaceutical-vesicle formulation comprising steps of: preparing and processing vesicle components and a pharmaceutical agent to entrap the pharmaceutical agent in the vesicle and form a pharmaceutical-vesicle formulation, wherein the pharmaceutical-vesicle formulation is reconstituted in a known quantity of the pharmaceutical agent dissolved in a pharmaceutically-acceptable carrier to provide a biphasic pharmaceutical-vesicle formulation. The invention also relates to the associated pharmaceutical-vesicle formulations, pharmaceutical kits and uses as a medicament, in particular for the prevention or treatment of infection by bacteria such as Burkholderia pseudomallei and Francisella tularensis, and viruses such as Venezuelan Equine Encephalitis Virus (VEEV).

Abstract: An immunogenic reagent which produces an immune response which is protective against Bacillus anthracis, said reagent comprising one or more polypeptides which together represent up to three domains of the full length Protective Antigen (PA) of B. anthracis or variants of these, and at least one of said domains comprises domain 1 or domain 4 of PA or a variant thereof. The polypeptides of the immunogenic reagent as well as full length PA are produced by expression from E. coli. High yields of polypeptide are obtained using this method. Cells, vectors and nucleic acids used in the method are also described and claimed.

Abstract: An immunogenic reagent which produces an immune response which is protective against Bacillus anthracis, said reagent comprising one or more polypeptides which together represent up to three domains of the full length Protective Antigen (PA) of B. anthracis or variants of these, and at least one of said domains comprises domain 1 or domain 4 of PA ro a variant thereof. The polypeptides of the immunogenic reagent as well as full length PA are produced by expression from E. coli. High yields of polypeptide are obtained using this method. Cells, vectors and nucleic acids used in the method are also described and claimed.

Abstract: An immunogenic agent which comprises a killed strain of Burkholderia pseudomallei, or a combination of components thereof which combination produces a protective immune response in an animal to whom it is administered, and which comprises at least two members selected from the group consisting of (i) a lipopolysaccharide of Burkholderia pseudomallei, (ii) a capsular polysaccharide of Burkholderia pseudomallei and (iii) a protein of Burkholderia pseudomallei or an immunogenic variant thereof or an immunogenic fragment of either of these, or a nucleic acid which expresses said protein, immunogenic variant or immunogenic fragment thereof in a host animal; for use in the prevention or treatment of infection by Burkholderia pseudomallei and/or Burkholderia mallei.

Abstract: An immunogenic reagent which produces an immune response which is protective against Bacillus anthracis, said reagent comprising one or more polypeptides which together represent up to three domains of the full length Protective Antigen (PA) of B. anthracis or variants of these, and at least one of said domains comprises domain 1 or domain 4 of PA or a variant thereof. The polypeptides of the immunogenic reagent as well as full length PA are produced by expression from E. coli. High yields of polypeptide are obtained using this method. Cells, vectors and nucleic acids used in the method are also described and claimed.

Abstract: Spore coat-associated proteins from members of Bacillus genera, and in particular spore-coat associated protein N (CotN), have utilization as adjuvants in vaccine formulations. The vaccine formulations most likely contain a virulence factor of bacterial origin, which in the case of Bacillus genera is the protective antigen.

Abstract: An immunogenic agent which comprises a killed strain of Burkholderia pseudomallei, or a combination of components thereof which combination produces a protective immune response in an animal to whom it is administered, and which comprises at least two members selected from the group consisting of (i) a lipopolysaccharide of Burkholderia pseudomallei, (ii) a capsular polysaccharide of Burkholderia pseudomallei and (iii) a protein of Burkholderia pseudomallei or an immunogenic variant thereof or an immunogenic fragment of either of these, or a nucleic acid which expresses said protein, immunogenic variant or immunogenic fragment thereof in a host animal; for use in the prevention or treatment of infection by Burkholderia pseudomallei and/or Burkholderia mallei.

Abstract: An immunogenic agent which comprises a killed strain of Burkholderia pseudomallei, or a combination of components thereof which combination produces a protective immune response in an animal to whom it is administered, and which comprises at least two members selected from the group consisting of (i) a lipopolysaccharide of Burkholderia pseudomallei, (ii) a capsular polysaccharide of Burkholderia pseudomallei and (iii) a protein of Burkholderia pseudomallei or an immunogenic variant thereof or an immunogenic fragment of either of these, or a nucleic acid which expresses said protein, immunogenic variant or immunogenic fragment thereof in a host animal; for use in the prevention or treatment of infection by Burkholderia pseudomallei and/or Burkholderia mallei.

Abstract: An immunogenic reagent which produces an immune response which is protective against Bacillus anthracis, said reagent comprising one or more polypeptides which together represent up to three domains of the full length Protective Antigen (PA) of B. anthracis or variants of these, and at least one of said domains comprises domain 1 or domain 4 of PA or a variant thereof. The polypeptides of the immunogenic reagent as well as full length PA are produced by expression from E. coli. High yields of polypeptide are obtained using this method. Cells, vectors and nucleic acids used in the method are also described and claimed.

Abstract: Spore coat-associated proteins from members of Bacillus genera, and in particular spore-coat associated protein N (CotN), have utilisation as adjuvants in vaccine formulations. The vaccine formulations most likely contain a virulence factor of bacterial origin, which in the case of Bacillus genera is the protective antigen.

Abstract: An immunogenic agent which comprises a killed strain of Burkholderia pseudomallei, or a combination of components thereof which combination produces a protective immune response in an animal to whom it is administered, and which comprises at least two members selected from the group consisting of (i) a lipopolysaccharide of Burkholderia pseudomallei, (ii) a capsular polysaccharide of Burkholderia pseudomallei and (iii) a protein of Burkholderia pseudomallei or an immunogenic variant thereof or an immunogenic fragment of either of these, or a nucleic acid which expresses said protein, immunogenic variant or immunogenic fragment thereof in a host animal; for use in the prevention or treatment of infection by Burkholderia pseudomallei and/or Burkholderia mallei.

Abstract: The use of (i) an antibody specific for Yersinia pestis F1-antigen, or a binding fragment thereof, or (ii) an antibody specific for Yersinia pestis V-antigen, or a binding fragment thereof, or a combination of (i) and (ii), in the production of a medicament for the treatment of infection by Yersinia pestis. It has been found that such treatments are effective therapies for Yersinia pestis infection. In addition, the combination produces a synergistic effect when used prophylactically.

Abstract: An immunogenic reagent which produces an immune response which is protective against Bacillus anthracis, said reagent comprising one or more polypeptides which together represent up to three domains of the full length Protective Antigen (PA) of B. anthracis or variants of these, and at least one of said domains comprises domain 1 or domain 4 of PA or a variant thereof. The polypeptides of the immunogenic reagent as well as full length PA are produced by expression from E. coli. High yields of polypeptide are obtained using this method. Cells, vectors and nucleic acids used in the method are also described and claimed.

Abstract: An aerosol formulation comprising a biodegradable microsphere comprising a non-living reagent, such as a sub-unit vaccine, that produces a protective immune response in a mammal to whom it is administered. Nebulizers and inhalers containing such formulations are also described and claimed.

Abstract: A recombinant microorganism comprises an asporogenic Bacillus subtilis strain in which a gene encoding a protease enzyme has been downregulated or inactivated. In particular sigma factorspoIIAC is inactivated such that the strain is asporogenic. These strains are particularly useful as expression vehicles for proteins such as protective antigen (PA) of Bacillus anthracis.

Abstract: A recombinant microorganism comprises an asporogenic Bacillus subtilis strain in which a gene encoding a protease enzyme has been downregulated or inactivated. In particular sigma factorspoIIAC is inactivated such that the strain is asporogenic. These strains are particularly useful as expression vehicles for proteins such as protective antigen (PA) of Bacillus anthracis.

Abstract: An immunogenic reagent which produces an immune response which is protective against Bacillus anthracis, said reagent comprising one or more polypeptides which together represent up to three domains of the full length Protective Antigen (PA) of B. anthracis or variants of these, and at least one of said domains comprises domain 1 or domain 4 of PA or a variant thereof. The polypeptides of the immunogenic reagent as well as full length PA are produced by expression from E. coli. High yields of polypeptide are obtained using this method. Cells, vectors and nucleic acids used in the method are also described and claimed.

Abstract: A pharmaceutical composition which comprises microparticles comprising (i) a biologically active compound capable of generating an immune response in an animal to which it is administered which is protective against a pathogen; (ii) a polymeric material capable of forming microspheres; and (iii) an immunostimulant comprising a phospholipid. The composition is particularly useful for the oral administration of vaccines.

Abstract: The present invention provides novel peptides and vaccines containing them capable or inducing production of antibodies directed against Clostridium perfringens alph-toxin (CPa) in animals to which the) arc administered and thereby providing pro-phylazis against infection by Clostridium pefringens and/or the alpha-toxin itself. Particularly the present invention provides such a vaccine that is relatively safe and simple to produce. e.g. by genetic engineering means. Preferred peptides comprise theo amino acid sequence of Clostridium perfringens alpha-toxin from amino acid 247 to 370 but lack the epitopes necessary for phos-pholipase C and/or sphingomyelin hydrolysing activity round between amino acids 1 to 240 of that sequence. Further provided are antisera and antibodies raised to the peptides and vaccines of the present invention, and particularly monoclonal antibodies and hybridoma cell lines for their production.