Inhalational botulism in rhesus macaques exposed to botulinum neurotoxin complex serotypes A1 and B1

Clinical and Vaccine Immunology

Volumn 17, Issue 9, 2010, Pages 1293-1304

  Sanford, Daniel C ^a   Barnewall, Roy E ^a   Vassar, Michelle L ^a   Niemuth, Nancy ^a   Metcalfe, Karen ^b   House, Robert V ^b   Henderson, Ian ^b,c   Shearer, Jeffry D ^b  

^a BATTELLE MEMORIAL INSTITUTE   (United States)

^b A CSC Company   (United States)

^c Emergent Biosolutions   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BOTULINUM TOXIN; BOTULINUM TOXIN A1; BOTULINUM TOXIN B1; BOTULINUM VACCINE; UNCLASSIFIED DRUG; VACCINE;

AEROSOL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; AUTOPSY; BODY WEIGHT; BOTULISM; DISEASE COURSE; DOSE RESPONSE; HEART RATE; HEMATOLOGY; HISTOPATHOLOGY; LETHAL DOSE; NONHUMAN; PRIORITY JOURNAL; RHESUS MONKEY; TELEMETRY;

AEROSOLS; ANIMALS; BLOOD CHEMICAL ANALYSIS; BODY WEIGHT; BOTULINUM TOXINS; BOTULINUM TOXINS, TYPE A; BOTULISM; DISEASE MODELS, ANIMAL; FEMALE; LETHAL DOSE 50; MACACA MULATTA; MALE; MICE; SURVIVAL ANALYSIS;

EID: 77956408837     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00080-10     Document Type: Article

References (23)

1. Aoki, K., and B. Guyer. 2001. Botulinum toxin type A and other botulinum toxin serotypes: a comparative review of biochemical and pharmacological actions. Eur. J. Neurol. 8(Suppl. 5):21-29.
2. Arnon, S. S., R. Schechter, T. V. Inglesby, D. A. Henderson, J. G. Bartlett, M. S. Ascher, E. Eitzen, A. D. Fine, J. Hauer, M. Layton, S. Lillibridge, M. T. Osterholm, T. O'Toole, G. Parker, T. M. Perl, P. K. Russell, D. L. Swerdlow, and K. Tonat. 2001. Botulinum toxin as a biological weapon: medical and public health management. JAMA 285:1059-1070.
3. Böhnel, H., and F. Gessler. 2005. Botulinum toxins - cause of botulism and systemic diseases? Vet. Res. Commun. 29:313-345.
4. Boles, J., M. West, V. Montgomery, R. Tammariello, M. L. Pitt, P. Gibbs, L. A Smith, and R. D. LeClaire. 2006. Recombinant C fragment of botulinum neurotoxin B serotype (rBoNTB (Hc)) immune response and protection in the rhesus monkey. Toxicon 47:877-884.
5. Byrne, M., and L. A. Smith. 2000. Development of vaccines for prevention of botulism. Biochimie 82:955-966.
6. Center for Drug Evaluation and Research. 2009. Guidance for industry. Animal models - essential elements to address efficacy under the animal rule. Food and Drug Administration, Department of Health and Human Services, Rockville, MD. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM078923.pdf.
7. Centers for Disease Control and Prevention. 1998. Botulism in the United States, 1899-1996: handbook for epidemiologists, clinicians, and laboratory workers. Public Health Service, U.S. Department of Health and Human Services, Atlanta, GA. http://www.cdc.gov/nczved/dfbmd/diseaselisting/files/botulism.pdf.
8. Centers for Disease Control and Prevention. 2010. Emergency Preparedness and Response Bioterrorism. Centers for Disease Control and Prevention, Atlanta, GA. http://www.bt.cdc.gov/agent/agentlist-category.asp.
9. Centers for Disease Control and Prevention. 2010. Botulism. Centers for Disease Control and Prevention, Atlanta, GA. http://www.cdc.gov/nczved /dfbmd/disease-listing/botulism-gi.html.
10. Department of Health and Human Services, U.S. Food and Drug Administration. 2009. Code of Federal Regulations, Title 21, vol. 7, subpart H. Approval of biological products when human efficacy studies are not ethical or feasible. 21CFR601. Department of Health and Human Services, U.S. Food and Drug Administration, Washington, DC.
11. Feder, P. I., D. W. Hobson, C. T. Olson, R. L. Joiner, and M. C. Matthews. 1992. Statistical design considerations for stagewise, adaptive dose allocation in dose-response studies, p. 37-86. In K. E. Peace (ed.), Biopharmaceutical sequential statistical applications. Marcel Dekker, New York, NY.
12. Feder, P. I., C. T. Olson, D. W. Hobson, M. C. Matthews, and R. L. Joiner. 1991. Statistical analysis of dose-response experiments by maximum likelihood analysis and iteratively reweighted nonlinear least squares regression techniques. Drug Inf. J. 25:323-334.
13. Finney, D. J. 1971. Probit analysis, 3rd ed. Cambridge University Press, Cambridge, England.
14. Franz, D. R., L. M. Pitt, M. A. Clayton, M. A. Hanes, and K. J. Rose. 1993. Efficacy of prophylactic and therapeutic administration of antitoxin for inhalation botulism, p. 473-476. In B. R. DasGupta (ed.), Botulism and tetanus neurotoxins: neurotransmission and biomedical aspects. Plenum Press, New York, NY.
15. Herrero, B. A., A. E. Ecklung, C. S. Streett, D. F. Ford, and J. K. King. 1967. Experimental botulism in monkeys: a clinical pathology study. Exp. Mol. Pathol. 6:84-95.
16. LeClaire, R. D., and L. M. Pitt. 2005. Agent effect levels, p. 54. In L. E. Lindler, F. J. Lebeda, and G. Korch (ed.), Biological weapons defense: infectious disease and counterbioterrorism. Humana Press, Totowa, NJ.
17. McCance, K. L., and S. E. Huether. 2002. Pathophysiology: the biologic basis for disease in adults and children, 4th ed. Elsevier Science, St. Louis, MO.
18. National Research Council. 1996. Guide for the care and use of laboratory animals. National Academy Press, Washington, DC.
19. Scott, A. B., and D. Suzuki. 1988. Systemic toxicity of botulinum toxin by intramuscular injection in the monkey. Mov. Disord. 3:333-335.
20. Simpson, L. L. 2004. Identification of the major steps in botulinum toxin action. Annu. Rev. Pharmacol. Toxicol. 44:167-193.
21. Smith, L. A., and J. M. Rusnak. 2007. Botulinum neurotoxin vaccines: past, present, and future. Crit. Rev. Immunol. 27:303-318.
22. Smith, L. A. 2009. Botulism and vaccines for its prevention. Vaccine 27:D33-D39.
23. Sobel, J. 2005. Botulism. Clin. Infect. Dis. 41:1167-1173.