Vaccine for clostridium botulinum neurotoxin

Details Vaccine for clostridium botulinum neurotoxin Vaccine for clostridium botulinum neurotoxin

1995-03-16

1999-07-06

Eisenschenk, Frank C.

Chemistry: molecular biology and microbiology

Micro-organism, tissue cell culture or enzyme using process...

Using a micro-organism to make a protein or polypeptide

4352523, 4353201, 530825, 530350, 536 234, C07K 1900, C12N 120, C12P 100

Patent

active

059196653

ABSTRACT:
The present invention includes recombinant proteins derived from Clostridium botulinum toxins. In particular, soluble recombinant Clostridium botulinum type A toxin proteins are provided. Methods which allow for the isolation of recombinant proteins free of significant endotoxin contamination are provided. The soluble, endotoxin-free recombinant proteins are used as immunogens for the production of vaccines and antitoxins. These vaccines and antitoxins are useful in the treatment of humans and other animals at risk of intoxication with clostridial toxin.

REFERENCES:
patent: 5080895 (1992-01-01), Tokoro
patent: 5196193 (1993-03-01), Carroll
patent: 5268295 (1993-12-01), Serrero
Kim et al., Gene, 1988, 68:315.
Sassenfeld et al., Trends in Biotechnology, 1990, 8:88.
Raupach et al., FEMS Immunol. Med. Microbiol., 1994, 8(3):197.
Afrin et al., Bioconj. Chem., 1994, 5:539.
Nygren et al., Trends Biotechnol., 1994, 12(5):184.
P.H.A. Sneath et al., "Clostridium," Bergey's Manual.RTM. of Systematic Bacteriology, vol. 2, pp. 1141-1200, Williams & Wilkins (1986).
P.G. Engelkirk et al., "Classification," Principles and Practice of Clinical Anaerobic Bacteriology, pp. 22-23, Star Publishing Co., Belmont, CA (1992).
J. Stephen and R.A. Petrowski, "Toxins Which Traverse Membranes and Deregulate Cells," in Bacterial Toxins, 2d ed., pp. 66-67, American Society for Microbiology (1986).
R. Berkow and A.J. Fletcher (eds.), "Bacterial Diseases," Merck Manual of Diagnosis and Therapy, 16th ed., pp. 119-126, Merck Research Laboratories, Rahway, N.J. (1992).
O.H. Siegmund and C.M. Fraser (eds.), "Clostridial Infections," Merck Veterinary Manual, 5th ed., pp. 396-409, Merck & Co., Rahway, N.J. (1979).
C.L. Hatheway, "Toxigenic Clostridia," Clin. Microbiol. Rev. 3:66-98 (1990).
S. Arnon, "Infant Botulism: Anticipating the Second Decade," J. Infect. Dis. 154:201-206 (1986).
S. Arnon, "Infant Botulism," Ann. Rev. Med. 31:541 (1980).
K.L. MacDonald et al., "The Changing Epidemiology of Adult Botulism in the United States," Am. J. Epidemiol. 124:794 (1986).
C.O. Tacket et al., "Equine Antitoxin Use and Other Factors That Predict Outcome in Type A Foodborne Botulism," Am. J. Med. 76:794 (1984).
M.N. Swartz, "Anaerobic Spore-Forming Bacilli: The Clostridia," pp. 633-646, in B.D. Davis et al., (eds.), Microbiology, 4th edition, J.B. Lippincott Co. (1990).
V.E. Holzer, "Botulismus durch Inhalation," Med. Klin. 41:1735 (1962).
D.R. Franz et al., "Efficacy of Prophylactic and Therapeutic Administration of Antitoxin For Inhalation Botulism," in Botulinum and Tetanus Neurotoxins, B.R. DasGupta, ed., Plenum Press, New York (1993), pp. 473-476.
S. Arnon et al., "Infant Botulism: Epidemiology and Relation to Sudden Infant Death Syndrome," Epidemiol. Rev. 3:45 (1981).
T.L. Frankovich and S. Arnon, "Clinical Trial of Botulism Immune Globulin for Infant Botulism," West. J. Med. 154:103 (1991).
H. Sugiyama, "Clostridium botulinum Neurotoxin," Microbiol. Rev. 44:419-48 (1980).
M. Balady, "Botulism Antitoxin Fielded for Operation Desert Storm," USAMRDC Newsletter, p. 6 (1991).
P.J. Schwarz and S.S. Arnon, "Botulism Immune Globulin for Infant Botulism Arrives--One Year and A Gulf War Later," Western J. Med. 156:197 (1992).
D.R. Peterson et al., "The Sudden Infant Death Syndrome and Infant Botulism," Rev. Infect. Dis. 1:630 (1979).
S. Arnon et al., "Intestinal Infection and Toxin Production by Clostridium Botulinum as One Cause of Sudden Infant Death Syndrome," Lancet, pp. 1273-1276, Jun. 17, 1978.
G.F. Brooks et al., (eds.) "Infections Caused by Anaerobic Bacteria," Jawetz, Melnick, & Adelberg's Medical Microbiology, 19th ed., pp. 257-262, Appleton & Lange, San Mateo, CA (1991).
P.G. Engelkirk et al., Principles and Practice of Clinical Anaerobic Bacteriology, pp. 64-67, Star Publishing Co., Belmont, CA (1992).
D.M. Lyerly et al., "Characterization of a Toxin A-Negative, Toxin B-Positive Strain of Clostridium difficile," Infect. Immun., 60:4633 (1992).
S.P. Borriello et al., "Virulence Factors of Clostridium difficile," Rev. Infect. Dis., 12(suppl. 2):S185 (1990).
D.M. Lyerly et al., "Effects of Clostridium difficile Toxins Given Intragastrically to Animals," Infect. Immun., 47:349-52 (1985).
R.D. Rolfe, "Binding Kinetics of Clostridium difficile Toxins A and B to Intestinal Brush Border Membranes from Infant and Adult Hamsters," Infect. Immun., 59:1223 (1990).
Kim and Rolfe, Abstr. Ann. Meet. Am. Soc. Microbiol., 69:62 (1987).
Banno et al., "Biochemical Characterization and Biologic Actions of Two Toxins (D-1 and D-2) From Clostridium difficile," Rev. Infect. Dis., 6 (Suppl. 1:S11-S20 (1984).
Rihn et al., "A New Purification Procedure for Clostridium difficile Enterotoxin," Biochem. Biophys. Res. Comm., 124:690-695 (1984).
Justus et al., "Myoelectric Effects of Clostridium difficile: Motility-Altering Factors Distinct From its Cytotoxin and Enterotoxin in Rabbits," Gastroenterol., 83:836-843 (1982).
S.M. Finegold et al., "Antimicrobial-Associated Pseudomembranous Colitis," Clinical Guide to Anaerobic Infections, pp. 88-89, Star Publishing Co., Belmont, CA (1992).
United States Pharmacopeia, vol. XXII (1990) United States Pharmacopeial Convention, Rockville, MD, pp. 1515-1516.
FDA Guidelines for Parenteral Drugs (Dec. 1987); i.e., Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices, Maintained by: Division of Manufacturing and Product Quality (HFN-320), Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD.
F.C. Pearson, Pyrogens: Endotoxins, LAL Testing and Depyrogenation, Marcel Dekker, New York (1985), pp. 150-155.
H.N. Benson et al., "Requirement of Avian C'1 for Fixation of Guinea Pig Complement by Avian Antibody-Antigen Complexes," J. Immunol. 87:616 (1961).
A.A. Benedict and K. Yamaga, "Immunoglobulins and Antibody Production in Avian Species," in Comparative Immunology (J.J. Marchaloni, ed.), pp. 335-375, Blackwell, Oxford (1966).
R. Patterson et al., "Antibody Production and Transfer to Egg Yolk in Chickens," J. Immunol. 89:272 (1962).
S.B. Carroll and B.D. Stollar, "Antibodies of Calf Thymus RNA Polymerase II from Egg Yolks of Immunized Hens," J. Biol. Chem. 258:24 (1983).
A. Polson et al., "Antibodies to Proteins from Yolk of Immunized Hens," Immunol. Comm. 9:495 (1980).
B.R. DasGupta and H. Sugiyama, "A Common Subunit Structure In Clostridium Botulinum Type A, B, and E Toxins," Biochem. Biophys. Res. Commun. 48:108-12 (1972).
B.R. DasGupta, "Structure and Biological Activity of Botulinum Neurotoxin," J. Physiol. 84:220-28 (1990).
G. Sakaguchi, "Clostridium Botulinum Toxins," Pharmac. Ther. 19:165-194 (1983).
L.J. Moberg and H. Sugiyama, "Affinity Chromatography Purification of Type A Botulinum Neurotoxin from Crystalline Toxic Complex," Appl. Environ. Microbiol. 35:878-80 (1978).
B.S. Thalley et al., "Development of an Avian Antitoxin to Type A Botulinum Neurotoxin," in Botulinum and Tetanus Neurotoxins, B.R. DasGupta, ed., Plenum Press, New York (1993), pp. 467-472.
E.J. Schantz and E.A. Johnson, "Properties and Use of Botulinum Toxin and Other Microbial Neurotoxins in Medicine," Microbiol. Rev. 56:80-99 (1992).
A.J. Makoff et al., "Expression of Tetanus Toxin Fragment C in E. Coli: Its Purification and Potential Use as a Vaccine," Bio/Technology 7:1043-46 (1989).
A.J. Makoff et al., "Expression of Tetanus Toxin Fragment C in E. Coli: High Level Expression By Removing Rare Codons," Nucleic Acids Res. 17:10191-10202 (1989).
J.L. Halpern et al., "Cloning and Expression of Functional Fragment C of Tetanus Toxin," Infect. Immun. 58:1004-09 (1990).
M.A. Romanos et al., "Expression of Tetanus Toxin Fragment C in Yeast: Gene Synthesis is Required to Eliminate Fortuitous Polyadenylation Sites in AT-Rich DNA," Nucleic Acids Res. 19:1461-67 (1991).
I.G. Charles et al., "Synthesis of Tetanus Toxin Fragment C in Insect Cells by Use of a Baculovirus Expression System," Infect. Immun. 59:1627-32 (1991).
M.R. Popoff et al., "Characterization of the C3 Gen

Affiliated with

Also associated with

Rating

Vaccine for clostridium botulinum neurotoxin does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Vaccine for clostridium botulinum neurotoxin, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Vaccine for clostridium botulinum neurotoxin will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-898504