Mutant cholera holotoxin as an adjuvant

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Combination of viral and bacterial antigens

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

C424S200100, C424S252100, C435S252300, C435S472000, C435S069300, C530S350000, C536S023700

Reexamination Certificate

active

07384640

ABSTRACT:
A mutant cholera holotoxin featuring a point mutation at amino acid 29 of the A subunit, wherein the glutamic acid residue is replaced by an amino acid other than aspartic acid, is useful as an adjuvant in an antigenic composition to enhance the immune response in a vertebrate host to a selected antigen from a pathogenic bacterium, virus, fungus or parasite. In a particular embodiment, the amino acid 29 is histidine. The mutant cholera holotoxin may contain at least one additional mutation in the A subunit at a position other than amino acid 29. The antigenic composition may include a second adjuvant in addition to the mutant cholera holotoxin.

REFERENCES:
patent: 4666829 (1987-05-01), Glenner et al.
patent: 5171568 (1992-12-01), Burke et al.
patent: 5182109 (1993-01-01), Tamura
patent: 5601831 (1997-02-01), Green et al.
patent: 5679352 (1997-10-01), Chong et al.
patent: 5709879 (1998-01-01), Barchfeld et al.
patent: 5770203 (1998-06-01), Burnette et al.
patent: 5925546 (1999-07-01), Pizza et al.
patent: 5965354 (1999-10-01), Burke et al.
patent: 5972336 (1999-10-01), Michetti et al.
patent: 6245337 (2001-06-01), St. Geme, III et al.
patent: 6290962 (2001-09-01), Michetti et al.
patent: 6395964 (2002-05-01), Arntzen et al.
patent: 6514503 (2003-02-01), Gizurarson et al.
patent: 6558677 (2003-05-01), Zollinger et al.
patent: 6685949 (2004-02-01), Gu et al.
patent: 2003/0113345 (2003-06-01), Clements
patent: 2004/0176571 (2004-09-01), Green et al.
patent: 2004/0181036 (2004-09-01), Green et al.
patent: WO-92/19265 (1992-11-01), None
patent: 93/13202 (1993-07-01), None
patent: WO 93/13202 (1993-07-01), None
patent: 95/17211 (1995-06-01), None
patent: WO 95/17211 (1995-06-01), None
patent: WO 96/06627 (1996-03-01), None
patent: 97/02348 (1997-01-01), None
patent: WO 97/02348 (1997-01-01), None
patent: WO 97/05267 (1997-02-01), None
patent: 97/29771 (1997-08-01), None
patent: WO 97/29771 (1997-08-01), None
patent: WO 98/32461 (1998-07-01), None
patent: WO 98/42375 (1998-10-01), None
patent: WO 98/45324 (1998-10-01), None
patent: WO-99/27944 (1999-06-01), None
patent: WO-02/098368 (2002-12-01), None
patent: WO-02/098369 (2002-12-01), None
Glineur, C et al, Importance of ADP-ribosylation in morphological changes of PC12 cells induced by cholera toxin. Infection and Immunity, vol. 62(10), 1994, pp. 4176-4185.
Locht, C et al, In R. Rappuoli, Bacterial protein toxins, supplement 19, Gustav Fisher Verlag, New York, 1990, pp. 89-90.
Vadheim, KL et al, Microb. Pathog. Nov. 1994, vol. 17(5), pp. 339-346. Expression and mutagenesis of recombinant cholera toxin A subunit.
O'Neal, C.M. et al, Journal of Virology, vol. 72(4), pp. 3390-3393, Apr. 1998, Rotavirus 2/6 viruslike particles administered intranasally with cholera toxin,Escherichia coliheat labile toxin (LT) and LT-R192G induce protection from rotavirus challen.
Orkin, SH et al, Dec. 7, 1995, Report and Recommendations of the Panel to assess the NIH investment in Research on gene therapy (see entire document).
Lobet, Y et al, Infection and Immunity, vol. 59(9), pp. 2870-2879, Sep. 1991.
Jobling, MG et al, Journal of Bacteriology, Jul. 2001, vol. 183(13), pp. 4024-4032.
Feil, Ik et al Molecular Microbiology, vol. 20(4), pp. 823-832, 1996.
Glineur, C et al , Infection and Immunity, vol. 62(10), pp. 4176-4185, 1994.
Zhang, Rong-Guang et al, J. Mol. Biol., 1995, pp. 563-573, vol. 251, The three dimensional crystal structure of Cholera toxin.
Vadheim, KL et al, Microbial pathogenesis, vol. 17, pp. 339-346, 1994.
Zhang et al (1995, p. 564, Figure 1, reference of record).
Gilneur et al (1994, reference of record).
Zhu et al., “Intragastric Immunization with RecombinantH. pyloriUrease Formulated with Attenuated Cholera Toxin Elicits Systemic, Mucosal and Protective Immune Responses in C57BL/6 Mice”,FASEB J., 13(4) Part 1: A291, Meeting Information: Annual Meeting of the Professional Research Scientists for Experimental Biology.
Jobling et al., “Biological and Biochemical Characterization of Variant A. Subunits of Cholera Toxin Constructed by Site-Directed Mutagenesis”,J. Bacteriol., 183(13): 4024-4032 (Jul. 2001).
Jobling et al., “Identification of Motifs in Cholera Toxin A1 Polypeptide that are Required for its Interaction with Human ADP-Ribosylation Factor 6 in a Bacterial Two-Hybrid System”,Proc. Natl. Acad. Sci.USA, 97(26):14662-14667 (Dec. 19, 2000).
Pizza et al., “Mucosal Vaccines: Non-Toxid Derivatives of LT and CT as Mucosal Adjuvants”,Vaccine: 2534-2541 (Mar. 21, 2001).
M. Guiliani et al., “Mucosal Adjvanticity and Immunogenicity of LTR72, A Noval Mutant ofEscherichia coliHeat Labile Enterotoxin with Partial Knockout of ADP-Ribosyltransferase Activity”,J. Exp. Med., 187(7):1123-1132 (Apr. 6, 1998).
Jobling, Michael G., Analysis of the Structure and Function of Cholera Toxin A Subunit, Abstracts of the General Meeting-1991, American Society for Microbiology, p. 59, Abstract No. B-205.
Glineur,Corine, Importance of ADP-Ribosylation in the Morphological Changes of PC12 Cells Induced by Cholera Toxin, Infection and Immunity, Oct. 1994, pp. 4176-4185, vol. 62, No. 10.
Lycke, N., Strong Adjuvant Properties of Cholera Toxin on Gut Mucosal Immune Responses to Orally Presented Antigens, Immunology, 1986, pp. 301-308, vol. 59.
McKenzie, Sara J., Cholera Toxin B Subunit as a Carrier Protein to Stimulate A Mucosal Immune Response, The Journal of Immunology, Oct. 1984, pp. 1818-1824, vol. 133, No. 4.
Mekalanos, John J., Cholera Toxin Genes: Nucleotide Sequence, Deletion Analysis and Vaccine Development, Nature, Dec. 8, 1983, pp. 551-557, vol. 306.
Nedrud, John, Oral Immunization Against Respiratory Viruses in Mice, Advances in Mucosal Immunology, 1995, vol. 371B, pp. 1595-1598.
Elson, Charles O., Generalized Systemic and Mucosal Immunity in Mice After Mucosal Stimulation with Cholera Toxin, The Journal of Immunology, Jun. 1984, pp. 2736-2741, vol. 132, No. 6.
Elson, Charles O., Cholera Toxin Feeding Did Not Induce Oral Tolerance in Mice and Abrogated Oral Tolerance to an Unrelated Protein Antigen, The Journal of Immunology, Dec. 1984, pp. 2892-2897, vol. 133, No. 6.
Richards, C.M., Enhancement of the Immune Response to Non-replicating Herpes Simplex Virus Type-1 Preparations by Mucosal Administration in the Presence of Cholera Toxin, Vaccine, 1997, pp. 1065-1069, vol. 15, No. 10.
Yamamoto, Shingo, Mutants in the ADP-ribosyltransferase Cleft of Cholera Toxin Lack Diarrheagenicity but Retain Adjuvanticity, J. Exp. Med., Apr. 7, 1997, pp. 1203-1210, vol. 185, No. 7.
Pachuk et al., “Humoral and Cellular Immune Response to Herpes Simplex Virus-2 Glycoprotein D Generated by Facilitated DNA Immunization of Mice”, in Current Topics in Microbiology and Immunology, Koprowski et al., Eds., Springer-Verlag, Berlin: vol. 226, pp. 79-89 (1998).
Audibert et al., “Adjuvants: current status, clinical perspectives and future prospects”, Immunology Today Jun. 1993 14:281-284.
Bazin et al., “Predominant contribution of IgA antibody-forming cells to an immune response detected in extraintestinal lymphoid tissues of germ-free mice exposed to antigen by the oral route” J. Immunol. Oct. 1970 105:1049-1051.
Brandtzaeg et al., “Immune functions of human nasal mucosa and tonsils in health and disease”, in Immunology of the Lung and Upper Respiratory Tract, Bienenstock, J. (Ed.) McGraw-Hill, New York 1984 p. 28.
Brandtzaeg et al., “Immunohistochemical characterization of local immunoglobulin formation in Crohn's disease of the ileum”, Scand. J. Gastroenterol. 1976 11:447-457.
Crabbe et al., “Antibodies of the IgA type in intestinal plasma cells of germfree mice after oral or parenteral immunization with ferritin”, J. Exp. Med. Oct. 1969 130:723-744.
Craig et al., “Peyer's patches: an enriched source of precursors for IgA-producing immunocytes in the rabbit” J. Exp. Med. Jul. 1971 134:188-200.
Cuatrecasas, P., “Gangliosides and membrane receptors for cholera toxin”, Biochem. Aug. 1973 12:3558-356

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Mutant cholera holotoxin as an adjuvant does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Mutant cholera holotoxin as an adjuvant, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Mutant cholera holotoxin as an adjuvant will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-2798518

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.