Phase I Study of Safety and Immunogenicity of an Escherichia coli-Derived Recombinant Protective Antigen (rPA) Vaccine to Prevent Anthrax in Adults

PLoS ONE

Volumn 5, Issue 11, 2010, Pages

  Brown, Bruce K ^a   Cox, Josephine ^a   Gillis, Anita ^a   van Cott, Thomas C ^a   Marovich, Mary ^b   Milazzo, Mark ^a   Antonille, Tanya Santelli ^a   Wieczorek, Lindsay ^a   McKee Jr , Kelly T ^c   Metcalfe, Karen ^c   Mallory, Raburn M ^c   Birx, Deborah ^b   Polonis, Victoria R ^b   Robb, Merlin L ^a  

^a HENRY M JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE   (United States)

^b WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

^c DynPort Vaccine Company LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADJUVANT; ALUMINUM HYDROXIDE; ANTHRAX VACCINE; ANTIGEN; IMMUNOGLOBULIN G; PLACEBO; RECOMBINANT PROTECTIVE ANTIGEN; RECOMBINANT PROTECTIVE ANTIGEN VACCINE; SODIUM CHLORIDE; UNCLASSIFIED DRUG; BACTERIAL ANTIGEN; BACTERIUM ANTIBODY; RECOMBINANT PROTEIN;

ADULT; ANTHRAX; ANTIBODY TITER; ARTICLE; CELLULAR IMMUNITY; CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG SAFETY; DRUG TOLERABILITY; ESCHERICHIA COLI; FOLLOW UP; HUMAN; HUMAN EXPERIMENT; HUMORAL IMMUNITY; IMMUNOGENICITY; INJECTION SITE REACTION; INJECTION SITE WARMTH; LYMPHOCYTE TRANSFORMATION TEST; NORMAL HUMAN; OPEN STUDY; PHASE 1 CLINICAL TRIAL; ADOLESCENT; BACILLUS ANTHRACIS; CELL PROLIFERATION; CHEMICALLY INDUCED DISORDER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOLOGY; DOSE RESPONSE; DRUG EFFECT; ENZYME LINKED IMMUNOSORBENT ASSAY; ERYTHEMA; FATIGUE; GENETICS; IMMUNOLOGY; LYMPHOCYTE; METHODOLOGY; PAIN; RANDOMIZED CONTROLLED TRIAL; VACCINATION;

BACILLUS ANTHRACIS; ESCHERICHIA COLI;

ADOLESCENT; ADULT; ANTHRAX; ANTHRAX VACCINES; ANTIBODIES, BACTERIAL; ANTIGENS, BACTERIAL; BACILLUS ANTHRACIS; CELL PROLIFERATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ENZYME-LINKED IMMUNOSORBENT ASSAY; ERYTHEMA; ESCHERICHIA COLI; FATIGUE; HUMANS; LYMPHOCYTES; PAIN; RECOMBINANT PROTEINS; VACCINATION; YOUNG ADULT;

EID: 78249284050     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0013849     Document Type: Article

References (25)

1. Young JA, Collier RJ (2007) Anthrax toxin: receptor binding, internalization, pore formation, and translocation. Annu Rev Biochem 76: 243-265.
2. Fellows PF, Linscott MK, Ivins BE, Pitt ML, Rossi CA, et al. (2001) Efficacy of a human anthrax vaccine in guinea pigs, rabbits, and rhesus macaques against challenge by Bacillus anthracis isolates of diverse geographical origin. Vaccine 19: 3241-3247.
3. Ivins BE, Fellows PF, Pitt ML, Estep JE, Welkos SL, et al. (1996) Efficacy of a standard human anthrax vaccine against Bacillus anthracis aerosol spore challenge in rhesus macaques. Salisbury Med Bull 87: 125-126.
4. Ivins BE, Pitt ML, Fellows PF, Farchaus JW, Benner GE, et al. (1998) Comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in rhesus macaques. Vaccine 16: 1141-1148.
5. Brachman PS, Gold H, Plotkin SA, Fekety FR, Werrin M, et al. (1962) Field Evaluation of a Human Anthrax Vaccine. Am J Public Health Nations Health 52: 632-645.
6. Turnbull PC (1991) Anthrax vaccines: past, present and future. Vaccine 9: 533-539.
7. Keitel WA (2006) Recombinant protective antigen 102 (rPA102): profile of a second-generation anthrax vaccine. Expert Rev Vaccines 5: 417-430.
8. TM) package insert.
9. Food and Drug Administration (2004) Biological products, bacterial vaccines and toxoids, implementation of efficacy review, anthrax vaccine adsorbed. Final order, 70 F.R. pp 75180-75198.
10. Niu MT, Ball R, Woo EJ, Burwen DR, Knippen M, et al. (2009) Adverse events after anthrax vaccination reported to the Vaccine Adverse Event Reporting System (VAERS), 1990-2007. Vaccine 27: 290-297.
11. Zink TK, Gorse GJ, et al. (2007) "Immunogenicity and tolerance of ascending doses of a recombinant protective antigen (rPA102) anthrax vaccine: a randomized, double-blinded, controlled, multicenter trial" [Vaccine 24 (2006) 5950-5959]. Vaccine 25: 2766-2767.
12. Gorse GJ, Keitel W, Keyserling H, Taylor DN, Lock M, et al. (2007) Response to letter to the editor "Zink TK. Vaccine 2007;25(15):2766-7". Vaccine 25: 7285-7287.
13. Gorse GJ, Keitel W, Keyserling H, Taylor DN, Lock M, et al. (2006) Immunogenicity and tolerance of ascending doses of a recombinant protective antigen (rPA102) anthrax vaccine: a randomized, double-blinded, controlled, multicenter trial. Vaccine 24: 5950-5959.
14. Campbell JD, Clement KH, Wasserman SS, Donegan S, Chrisley L, et al. (2007) Safety, reactogenicity and immunogenicity of a recombinant protective antigen anthrax vaccine given to healthy adults. Hum Vaccin 3: 205-211.
15. Quinn CP, Semenova VA, Elie CM, Romero-Steiner S, Greene C, 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.
16. Quinn CP, Dull PM, Semenova V, Li H, Crotty S, et al. (2004) Immune responses to Bacillus anthracis protective antigen in patients with bioterrorismrelated cutaneous or inhalation anthrax. J Infect Dis 190: 1228-1236.
17. Ratto-Kim S, Garner RP, Kim JH, Jagodzinski LL, Michael NL, et al. (2004) Prospective analyses of HIV-1-specific proliferative responses, recall antigen proliferative responses, and clinical outcomes in an HIV-1-seropositive cohort. J Infect Dis 189: 1988-1995.
18. Pittman PR, Norris SL, Barrera Oro JG, Bedwell D, Cannon TL, et al. (2006) Patterns of antibody response in humans to the anthrax vaccine adsorbed (AVA) primary (six-dose) series. Vaccine 24: 3654-3660.
19. TM) package insert.
20. Belton FC, Darlow HM, Henderson DW (1956) The use of anthrax antigen to immunise man and monkey. Lancet 271: 476-479.
21. Pitt ML, Little SF, Ivins BE, Fellows P, Barth J, et al. (2001) In vitro correlate of immunity in a rabbit model of inhalational anthrax. Vaccine 19: 4768-4773.
22. Little SF, Ivins BE, Fellows PF, Pitt ML, Norris SL, et al. (2004) Defining a serological correlate of protection in rabbits for a recombinant anthrax vaccine. Vaccine 22: 422-430.
23. Reuveny S, White MD, Adar YY, Kafri Y, Altboum Z, et al. (2001) Search for correlates of protective immunity conferred by anthrax vaccine. Infect Immun 69: 2888-2893.
24. Allen JS, Skowera A, Rubin GJ, Wessely S, Peakman M (2006) Long-lasting T cell responses to biological warfare vaccines in human vaccinees. Clin Infect Dis 43: 1-7.
25. Doolan DL, Freilich DA, Brice GT, Burgess TH, Berzins MP, et al. (2007) The US capitol bioterrorism anthrax exposures: clinical epidemiological and immunological characteristics. J Infect Dis 195: 174-184.