Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Recombinant or stably-transformed bacterium encoding one or...
Reexamination Certificate
2005-06-14
2005-06-14
Smith, Lynette R. F. (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Recombinant or stably-transformed bacterium encoding one or...
C424S184100, C424S200100, C424S234100, C424S235100, C424S253100, C424S256100, C424S257100, C424S258100, C424S259100, C424S278100, C435S007350, C435S007370, C435S023000, C435S024000, C435S038000, C435S069100, C435S069300, C435S320100, C435S440000
Reexamination Certificate
active
06905691
ABSTRACT:
The invention relates to a vaccine comprising a bacterium attenuated by a non-reverting mutation in a gene encoding a protein which promotes folding of extracytoplasmic proteins. Such mutations were initially identified as being useful in vaccines from a bank of randomly inserted, transposon mutants in which attenuation was determined as a reduction in virulence of the organism in the mouse model of infection. Site directed mutation of the gene results in a strain which shows at least 4 logs of attenuation when delivered both orally and intravenously. Animals vaccinated with such a strain are protected against subsequent challenge with the parent wild type strain. Finally, heterologous antigens such as the non-toxic and protective, binding domain from tetanus toxin, fragment C, can be delivered via the mucosal immune system using such strains of bacteria. This results in the induction of a fully protective immune response to subsequent challenge with native tetanus toxin.
REFERENCES:
patent: 5527529 (1996-06-01), Dougan et al.
patent: 5804194 (1998-09-01), Dougan et al.
patent: 0 322 237 (1989-06-01), None
patent: 0 400 958 A2 (1990-12-01), None
patent: 0 524 205 (1993-01-01), None
patent: WO 92/15689 (1992-09-01), None
patent: WO 94/03615 (1994-02-01), None
Lazar et al. 1996. J. of Bacteriology. 178(6): 1770-1773.
Missiakas et al. 1996. Mol. Micro. 21(4): 871-884.
Rouviere et al. 1996. Genes and Develop. 10: 3170-3182.
Boslego et al., “Gonorrhea Vaccines,” chapter 17 of Cryz, Jr., ed.,Vaccines and Immunotherapy, Pergamon Press, New York, 1991, pp. 221-223.
Ellis, “New Technologies for Making Vaccines,” chapter 29 of Plotkin et al., eds.,Vaccines, W.B. Saunders Company, Philadelphia, 1988, pp. 568-575.
Chatfield et al., “Live Salmonella as Vaccines and Carriers of Foreign Antigenic Determinants,”Vaccine, 7:495-498 (1989).
Hottenrott et al., “TheEscherichia coliSlyD is a Metal Ion-regulated Peptidyl-prolyl cis/trans -Isomerase,”J. Biol. Chem., 272:15697-15701 (1997).
Kleerebezem et al., “Characterization of anEscherichia colirotA Mutant, Affected in Periplasmic Peptidyl-prolyl cis/trans Isomerase,”Molecular Microbiology, 18:313-320 (1995).
Lazar et al., “SurA Assists the Folding ofEscherichia coliOuter Membrane Proteins,”J. Bacteriology, 178:1770-1773 (1996).
Lazar et al., “Role of theEscherichia coliSurA Protein in Stationary-Phase Survival,”J. Bacteriology, 180:5704-5711 (1998).
Liu et al., “Rearrangements in the Genome of the BacteriumSalmonella typhi,”Proc. Nat. Acad. Sci. USA, 92:1018-1022 (1995).
Missiakas et al., “New Components of Protein Folding in Extracytoplasmic Compartments ofEscherichia coliSurA, FkpA and Skp/OmpH,”Molecular Microbiology, 21:871-884 (1996).
Rouviere et al., “SurA, a Periplasmic Protein with Peptidyl-prolyl Isomerase Activity, Participates in the Assembly of Outer Membrane Porins,”Genes Dev., 10:3170-3182 (1996).
Rudd et al., “A New Family of Peptidyl-prolyl Isomerase,”Trends in Biochemical Sciences, 20:12-14 (1995).
Schodel et al., “Salmonellae as Oral Vaccine Carriers,”Dev. Biol. Stand., 84:245-253 (1995).
Bacon et al., “The Effects of Biochemical Mutation on the Virulence ofBacterium typhosum: The Virulence of Mutants,”Br. J. Exp. Pathol., 31:714-724 (1950).
Chatfield et al., “Evaluation ofSalmonella typhimuriumStrains Harbouring Defined Mutations in htrA and aroA in the Murine Salmonellosis Model,”Microbiol. Pathog., 12:145-151 (1992).
Chatfield et al., “Use of the nirB Promoter to Direct the Stable Expression of Heterologous Antigens in Salmonella Oral Vaccine Strains: Development of a Single-Dose Oral Tetanus Vaccine,”Bio/Technology, 10:888-892 (1992).
Chatfield et al., “Construction of a Genetically DefinedSalmonella typhiTy2 aroA, aroC Mutant for the Engineering of a Candidate Oral Typhoid-Tetanus Vaccine,”Vaccine, 10(1):53-60 (1992).
Curtiss III et al., “Salmonella typhimuriumDeletion Mutants Lacking Adenylate Cyclase and Cyclic AMP Receptor Protein are Avirulent and Immunogenic,”Infect. Immun., 55(12):3035-3043 (1987).
Dougan et al., “Construction and Characterization of Vaccine Strains of Salmonella Harboring Mutations in Two Different aro Genes,”J. Inf. Dis., 158(6):1329-1335 (1988).
Everest et al., “Expression of LacZ from the htrA, nirB and groE Promoters in a Salmonella Vaccine Strain: Influence of Growth in Mammalian Cells,”FEMS Microbiol. Letts., 126:97-101 (1995).
Fairweather et al., “Immunization of Mice Against Tetanus with Fragments of Tetanus Toxin Synthesized inEscherichia coli,”Infect. Immun., 55(11):2541-2545 (1987).
Fairweather et al., “Oral Vaccination of Mice Against Tetanus by Use of a Live Attenuated Salmonella Carrier,”Infect Immun., 58(5):1323-1326 (1990).
Gomaz-Duarte et al., “Expression of Fragment C of Tetanus Toxin Fused to a Carboxyl-Terminal Fragment of Diphtheria Toxin inSalmonella typhiCVD 908 Vaccine Strain,”Vaccine, 13(16):1596-1602 (1995).
Harrison et al., “Role of hns in the Virulence Phenotype of Pathogenic Salmonellae,”Mol. Micro., 13(1):133-140 (1994).
Hohmann et al., “Evaluation of a phoPlphoQ-deleted, aroA-deleted Live OralSalmonella typhiVaccine Strain in Human Volunteers,”Vaccine, 14(1):19-24 (1996).
Hone et al., “Construction of Defined galE Mutants of Salmonella for Use as Vaccines,”J. Infect. Dis., 156(1):167-174 (1987).
Hull et al., “Construction and Expression of Recombinant Plasmids Encoding Type 1 or D-Mannose-Resistant Pili from a Urinary Tract InfectionEscherichia coliIsolate,”Infect. Immun., 33(3):933-938 (1981).
Johnson et al., “The Role of a Stress-Response Protein inSalmonella typhimuriumVirulence,”Mol. Micro., 5(2):401-407 (1991).
Jones et al., “Oral Vaccination of Calves Against Experimental Salmonellosis Using a Double aro Mutant ofSalmonella typhimurium, ”Vaccine, 9:29-34 (1991).
Levine et al., “Attenuated Salmonella as Live Oral Vaccines Against Typhoid Fever and as Live Vectors,”J. Biotech., 44:193-196 (1996).
Manoil et al., “TnphoA: A Transposon Probe for Protein Export Signals,”Proc. Natl. Acad. Sci., USA, 82:8129-8133 (1985).
Miles et al., “The Estimation of the Bactericidal Power of the Blood,”J. Hygiene, 38:732-749 (1938).
Miller et al., “Bacteriophage P22 as a Vehicle for Transducing Cosmid Gene Banks Between Smooth Strains ofSalmonella typhimurium: Use in Identifying a Role for aroD in Attenuating Virulent Salmonella Strains,”Mol. Gen. Genet., 215:312-316 (1989).
Miller et al., “Isolation of Orally AttenuatedSalmonella typhimuriumFollowing TnphoA Mutagenesis,”Infect. Immun., 57(9):2758-2763 (1989).
Miller et al., “A Two-Component Regulatory System (phoP phoQ) ControlsSalmonella typhimuriumVirulence,”Proc. Natl. Acad. Sci., USA, 86:5054-5058 (1989).
Miller et al., “A Novel Suicide Vector and Its Use in Construction of Insertion Mutations: Osmoregulation of Outer Membrane Proteins and Virulence Determinants inVibrio choleraeRequires toxR,”J. Bact., 170(6):2575-2583 (1988).
Oxer et al., “High Level Heterologous Expression inE.coliUsing the Anaerobically-Activated nirB Promoter,”Nucl. Acids Res., 19(11):2889-2892 (1991).
Pickard et al., “Characterization of Defined ompR Mutants ofSalmonella typhi: ompR is Involved in the Regulation of Vi Polysaccharide Expression,”Infect. Immun., 62(9):3984-3993 (1994).
Reed et al., “A Simple Method of Estimating Fifty Per Cent Endpoints,”Am. J. Hygiene, 27(3):493-497 (1938).
Roberts et al., “A Mutant Pertussis Toxin Molecule That Lacks ADP-Ribosyltransferase Activity, PT-9K/129G, is an Effective Mucosal Adjuvant for Intranasally Delivered Proteins,”Infect. Immun., 63(6):2100-2108 (1995).
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Chatfield Steven Neville
Dougan Gordon
Sydenham Mark
Celltech Pharma Europe Limited
Hines J.
Popovich, Wiles & O'Connell , P.A.
Smith Lynette R. F.
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