Phase 1 study of a recombinant mutant protective antigen of Bacillus anthracis

Clinical and Vaccine Immunology

Volumn 19, Issue 2, 2012, Pages 140-145

  Bellanti, Joseph A ^b   Lin, Feng Ying C ^a   Chu, Chiayung ^a   Shiloach, Joseph ^c   Leppla, Stephen H ^d   Benavides, German A ^b   Karpas, Arthur ^a   Moayeri, Mahtab ^d   Guo, Chunyan ^a   Robbins, John B ^a   Schneerson, Rachel ^a  

^a EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^b GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES   (United States)

^d NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM POTASSIUM SULFATE; ANTHRAX VACCINE; BACTERIAL ANTIGEN; IMMUNOGLOBULIN G; IMMUNOGLOBULIN G ANTIBODY; RECOMBINANT MUTANT PROTECTIVE ANTIGEN; UNCLASSIFIED DRUG;

ABNORMAL LABORATORY RESULT; ADULT; ANTHRAX; ANTIBODY RESPONSE; ARTICLE; BACILLUS ANTHRACIS; BACTERIAL STRAIN; CONTROLLED STUDY; CORRELATION COEFFICIENT; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; HUMAN EXPERIMENT; INJECTION SITE COLORATION; INJECTION SITE PAIN; INJECTION SITE SWELLING; NAUSEA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN DEGRADATION; RANDOMIZED CONTROLLED TRIAL; SERODIAGNOSIS; SERUM BACTERICIDAL ANTIBODY ASSAY; STOMACH PAIN; VOMITING;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; ANTHRAX; ANTHRAX VACCINES; ANTIBODIES, BACTERIAL; ANTIBODY FORMATION; ANTIGENS, BACTERIAL; BACILLUS ANTHRACIS; BACTERIAL TOXINS; FEMALE; HUMANS; MALE; MIDDLE AGED; RECOMBINANT PROTEINS; VACCINES, SYNTHETIC; YOUNG ADULT;

EID: 84856417753     PISSN: 15566811     EISSN: 1556679X     Source Type: Journal    
DOI: 10.1128/CVI.05556-11     Document Type: Article

References (28)

1. Anonymous. 2007. US biodefence-shocking and awful. Nat. Biotechnol. 25:603.
2. Ashkenazi S, et al. 1999. Safety and immunogenicity of Shigella sonnei and Shigella flexneri 2a O-specific polysaccharide conjugates in children. J. Infect. Dis. 179:1565-1568. (Pubitemid 29246612)
3. Avashia SB, et al. 2007. Fatal pneumonia among metal workers due to inhalation exposure to Bacillus cereus containing Bacillus anthracis toxin genes. Clin. Infect. Dis. 44:414-416. (Pubitemid 46147625)
4. Brachman PS, et al. 1962. Field evaluation of a human anthrax vaccine. Am. J. Public Health Nations Health 52:632-645.
5. Campbell JD, et al. 2007. Safety, reactogenicity and immunogenicity of a recombinant protective antigen anthrax vaccine given to healthy adults. Hum. Vaccin. 3:205-211. (Pubitemid 47598179)
6. Centers for Disease Control and Prevention. 2000. Use of anthrax vaccine in the United States. Advisory Committee on Immunization Practices (ACIP).MMWRRecommend. Rep. 49(RR-15):1-20. http://www.cdc.gov /mmwr/preview/mmwrhtml/rr4915a1.htm.
7. Chen Z, et al. 2009. Potent neutralization of anthrax edema toxin by a humanized monoclonal antibody that competes with calmodulin for edema factor binding. Proc. Natl. Acad. Sci. U. S. A. 106:13487-13492.
8. Chen Z, et al. 2011. Pre- and postexposure protection against virulent anthrax infection in mice by humanized monoclonal antibodies to Bacillus anthracis capsule. Proc. Natl. Acad. Sci. U. S. A. 108:739-744.
9. Hoffmaster AR, et al. 2006. Characterization of Bacillus cereus isolates associated with fatal pneumonias: strains are closely related to Bacillus anthracis and harbor B. anthracis genes. J. Clin. Microbiol. 44:3352-3360. (Pubitemid 44413776)
10. Hoffmaster AR, et al. 2004. Identification of anthrax toxin genes in a Bacillus cereus associated with an illness resembling inhalation anthrax. Proc. Natl. Acad. Sci. U. S. A. 101:8449-8454. (Pubitemid 38736595)
11. Kaya A, Tasyaran MA, Erol S, Ozkurt Z, Ozkan B. 2002. Anthrax in adults and children: a review of 132 cases in Turkey. Eur. J. Clin. Microbiol. Infect. Dis. 21:258-261. (Pubitemid 34507869)
12. Klee SR, et al. 2006. Characterization of Bacillus anthracis-like bacteria isolated from wild great apes from Cote d'Ivoire and Cameroon. J. Bacteriol. 188:5333-5344. (Pubitemid 44157289)
13. Leppla SH, Robbins JB, Schneerson R, Shiloach J. 2002. Development of an improved vaccine for anthrax. J. Clin. Invest. 110:141-144. (Pubitemid 34787347)
14. Little SF, et al. 2004. Defining a serological correlate of protection in rabbits for a recombinant anthrax vaccine. 22:422-430.
15. Morano N, et al. 2008. Effects of a reduced dose schedule and intramuscular administration of anthrax vaccine adsorbed on immunogenicity and safety at 7 months. JAMA 81:1532-1543.
16. Pitt ML, et al. 2001. In vitro correlate of immunity in a rabbit model of inhalational anthrax vaccine. 19:4768-4773.
17. Pittman PR, et al. 2006. Patterns of antibody response in humans to the anthrax vaccine adsorbed (AVA) primary (six-dose) series. Vaccine 24: 3654-3660.
18. Pomerantsev AP, et al. 2011. A Bacillus anthracis strain deleted for six proteases serves as an effective host for production of recombinant proteins. Protein Expr. Purif. 80:80-90.
19. Porro M, Saletti M, Nencioni L, Tagliaferri L, Marsili I. 1980. Immunogenic correlation between cross-reacting material (CRM197) produced by a mutant of Corynebacterium diphtheriae and diphtheria toxoid. J. Infect. Dis. 142:716-724. (Pubitemid 11138425)
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. Ramirez DM, Leppla SH, Schneerson R, Shiloach J. 2002. Production, recovery and immunogenicity of the protective antigen from a recombinant strain of Bacillus anthracis. J. Ind. Microbiol. Biotechnol. 28:232-238. (Pubitemid 34461784)
22. Schneerson R, et al. 2003. Poly(gamma-D-glutamic acid) protein conjugates induce IgG antibodies in mice to the capsule of Bacillus anthracis: a potential addition to the anthrax vaccine. Proc. Natl. Acad. Sci. U. S. A. 100:8945-8950. (Pubitemid 36899203)
23. Singer DE, et al. 2008. Serum IgG antibody response to the protective antigen (PA) of Bacillus anthracis induced by anthrax vaccine adsorbed (AVA) among U.S. military personnel. Vaccine 26:869-873.
24. Singh Y, Klimpel KR, Arora N, Sharma M, Leppla SH. 1994. The chymotrypsin-sensitive site, FFD315, in anthrax toxin protective antigen is required for translocation of lethal factor. J. Biol. Chem. 269:29039-29046.
25. Sirisanthana T, Brown AE. 2002. Anthrax of the gastrointestinal tract. Emerg. Infect. Dis. 8:649-651. (Pubitemid 34764726)
26. Taft SC, Weiss AA. 2008. Neutralizing activity of vaccine-induced antibodies to two Bacillus anthracis toxin components, lethal factor and edema factor. Clin. Vaccine Immunol. 15:71-75. (Pubitemid 351966536)
27. Turnbull PC, Leppla SH, Broster MG, Quinn CP, Melling J. 1988. Antibodies to anthrax toxin in humans and guinea pigs and their relevance to protective immunity. Med. Microbiol. Immunol. 177:293-303.
28. Wright AM, et al. 2011. Rapidly progressive, fatal, inhalation anthraxlike infection in a human: case report, pathogen genome sequencing, pathology, and coordinated response. Arch. Pathol. Lab. Med. 135: 1447-1459.