Recombinant protective antigen anthrax vaccine improves survival when administered as a postexposure prophylaxis countermeasure with antibiotic in the New Zealand white rabbit model of inhalation anthrax

Clinical and Vaccine Immunology

Volumn 19, Issue 8, 2012, Pages 1158-1164

  Leffel, Elizabeth K ^a   Bourdage, James S ^a,c   Williamson, E Diane ^b   Duchars, Matthew ^a,d   Fuerst, Thomas R ^a   Fusco, Peter C ^a  

^a PharmAthene Inc   (United States)

^b DEFENCE SCIENCE AND TECHNOLOGY LABORATORY   (United Kingdom)

^c Lead Optimization Toxicology and Pharmacology   (United States)

^d Genie Biologic LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRAX VACCINE; IMMUNOGLOBULIN G ANTIBODY; LEVOFLOXACIN;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ANTHRAX; ANTIBODY RESPONSE; ARTICLE; BACILLUS ANTHRACIS; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG EFFICACY; IMMUNE RESPONSE; IMMUNOGENICITY; INFECTION PREVENTION; INFECTION RESISTANCE; NONHUMAN; PRIORITY JOURNAL; RABBIT; SURVIVAL RATE;

ANIMALS; ANTHRAX; ANTHRAX VACCINES; ANTI-BACTERIAL AGENTS; ANTIBIOTIC PROPHYLAXIS; ANTIGENS, BACTERIAL; BACTERIAL TOXINS; DISEASE MODELS, ANIMAL; DRUG THERAPY, COMBINATION; HUMANS; IMMUNOGLOBULIN G; OFLOXACIN; POST-EXPOSURE PROPHYLAXIS; RABBITS; RECOMBINANT PROTEINS; RESPIRATORY TRACT INFECTIONS; SURVIVAL ANALYSIS; TREATMENT OUTCOME; VACCINATION;

EID: 84864554649     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.00240-12     Document Type: Article

References (26)

1. Brachman PS, Kaufman AF, Dalldorf FG. 1966. Industrial inhalation anthrax. Bacteriol. Rev. 30:646-659.
2. Centers for Disease Control and Prevention. 2002. Notice to readers: use of anthrax vaccine in response to terrorism: supplemental recommendations of the Advisory Committee on Immunization Practices. MMWR Morb. Mortal. Wkly. Rep. 51:1024-1026.
3. Chien SC, et al. 1997. Pharmacokinetic profile of levofloxacin following once-daily 500-milligram oral or intravenous doses. Antimicrob. Agents Chemother. 41:2256-2260.
4. .Code of Federal Regulations. 2012. Title 21. Food and drugs. Chapter I. Food and Drug Administration. Subchapter F. Biolologics. Part 601. Licensing. CFR 601.90. http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol7/xml/CFR-2011- title21-vol7-part601-subpartH.xml.
5. FDA. 2010. November 16-17, 2010: Vaccines and Related Biological Products Advisory Committee meeting summary minutes. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD.
6. FDA. 2010. Pathway to licensure for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using the animal rule. Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD.
7. Fish DN, Chow AT. 1997. The clinical pharmacokinetics of levofloxacin. Clin. Pharmacokinet. 32:101-119. (Pubitemid 27104410)
8. Glassman HN. 1966. Industrial inhalation anthrax, discussion. Bacteriol. Rev. 30:657-659.
9. Henderson D. 1956. Observations on the prophylaxis of experimental pulmonary anthrax in the monkey. J. Hyg. (Lond.) 54:28-36.
10. Jernigan JA, et al. 2001. Bioterrorism-related inhalational anthrax: the first 10 cases reported in the United States. Emerg. Infect. Dis. 7:933-944.
11. Kobiler D, et al. 2006. Protective antigen as a correlative marker for anthrax in animal models. Infect. Immun. 74:5871-5876. (Pubitemid 44484574)
12. Leffel EK, Pitt MLM. 2006. Anthrax, p 84-86. In Swearengen J (ed), Biodefense research methodology and animal models. CRC Press, Boca Raton, FL.
13. Lubasch A, Keller I, Borner K, Koeppe P, Lode H. 2000. Comparative pharmacokinetics of ciprofloxacin, gatifloxacin, grepafloxacin, levofloxacin, trovafloxacin, and moxifloxacin after single oral administration in healthy volunteers. Antimicrob. Agents Chemother. 44:2600-2603.
14. Meselson M, et al. 1994. The Sverdlovsk anthrax outbreak of 1979. Science 266:1202-1208. (Pubitemid 24371272)
15. Mosmann T. 1983. Rapid colorimetric assay for cellular growth and survival: application to proliferation and cytotoxicity assays. J. Immunol. Methods 65:55-63. (Pubitemid 14203433)
16. National Biodefense and Countermeasures Center. 2006. Biological threat risk assessment. National Biodefense and Countermeasures Center, Department of Homeland Security, Ft. Detrick, MD.
17. Peterson JW, et al. 2010. Protection afforded by fluoroquinolones in animal models of respiratory infections with Bacillus anthracis, Yersinia pestis, and Francisella tularensis. Open Microbiol. J. 4:34-46.
18. Phipps AJ, Premanandan C, Barnewall RE, Lairmore MD. 2004. Rabbit and nonhuman primate models of toxin-targeting human anthrax vaccines. Microbiol. Mol. Biol. Rev. 68:617-629. (Pubitemid 39628529)
19. Quinn CP, et al. 2004. Immune responses to Bacillus anthracis protective antigen in patients with bioterrorism-related cutaneous or inhalation anthrax. J. Infect. Dis. 190:1228-1236. (Pubitemid 39287748)
20. Quinn CP, et al. 2002. Specific, sensitive, and quantitative enzyme-linked immunosorbent assay for human immunoglobulin G antibodies to anthrax toxin protective antigen. Emerg. Infect. Dis. 8:1103-1110. (Pubitemid 35257002)
21. Ross J. 1957. The pathogenesis of anthrax following the administration of spores by the respiratory route. J. Pathol. Bacteriol. 73:485.
22. Shepard CW, et al. 2002. Antimicrobial postexposure prophylaxis for anthrax: adverse events and adherence. Emerg. Infect. Dis. 8:1124-1132. (Pubitemid 35257005)
23. Vietri NJ, et al. 2006. Short-course postexposure antibiotic prophylaxis combined with vaccination protects against experimental inhalational anthrax. Proc. Natl. Acad. Sci. U. S. A. 103:7813-7816.
24. Weiss S, et al. 2006. Immunological correlates for protection against intranasal challenge of Bacillus anthracis spores conferred by a protective antigen-based vaccine in rabbits. Infect. Immun. 74:394-398. (Pubitemid 43023096)
25. Yee SB, Hatkin JM, Dyer DN, Orr SA, Pitt ML. 2010. Aerosolized Bacillus anthracis infection in New Zealand white rabbits: natural history and intravenous levofloxacin treatment. Comp. Med. 60:461-468.
26. Zaucha GM, Pitt LM, Estep J, Ivins BE, Friedlander AM. 1998. The pathology of experimental anthrax in rabbits exposed by inhalation and subcutaneous inoculation. Arch. Pathol. Lab. Med. 122:982-992. (Pubitemid 28521045)