Comparability of ELISA and toxin neutralization to measure immunogenicity of Protective Antigen in mice, as part of a potency test for anthrax vaccines

Vaccine

Volumn 27, Issue 33, 2009, Pages 4537-4542

  Parreiras, P M ^a,b   Sirota, L A ^b   Wagner, L D ^b   Menzies, S L ^b   Arciniega, J L ^b  

^a INSTITUTO OSWALDO CRUZ   (Brazil)

^b CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

Anthrax; Potency; Vaccine

Indexed keywords

ANTHRAX VACCINE; RECOMBINANT PROTECTIVE ANTIGEN; UNCLASSIFIED DRUG;

ANIMAL CELL; ANIMAL EXPERIMENT; ANTIBODY RESPONSE; ARTICLE; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DRUG POTENCY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; IMMUNIZATION; IMMUNOASSAY; IMMUNOGENICITY; INTERMETHOD COMPARISON; MOUSE; NONHUMAN; PRIORITY JOURNAL; TOXIN NEUTRALIZATION ASSAY;

ANIMALS; ANTHRAX; ANTHRAX VACCINES; ANTIBODIES, BACTERIAL; ANTIGENS, BACTERIAL; BACTERIAL TOXINS; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; MICE; NEUTRALIZATION TESTS; RECOMBINANT PROTEINS; VACCINES, SYNTHETIC;

EID: 67649464197     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2009.05.045     Document Type: Article

References (33)

1. Schmid G., and Kaufmann A. Anthrax in Europe: its epidemiology, clinical characteristics, and role in bioterrorism. Clin Microbiol Infect 8 8 (2002) 479-488
2. Advisory Committee on Immunization Practices. Use of anthrax vaccine in the United States. MMWR 49 RR15 (2000) 1-20
3. Chang M.H., Glynn M.K., and Groseclose S.L. Endemic, notifiable bioterrorism-related diseases, United States, 1992-1999. Emerg Infect Dis 9 5 (2003) 556-564
4. Zilinskas R.A. Iraq's biological weapons. The past as future?. JAMA 278 5 (1997) 418-424
5. CDC. Recognition of illness associated with the intentional release of a biologic agent. MMWR 50 41 (2001) 893-897
6. Gerberding J.L., Hughes J.M., and Koplan J.P. Bioterrorism preparedness and response: clinicians and public health agencies as essential partners. JAMA 287 7 (2002) 898-900
7. Smith B.T., Inglesby T.V., and O'Toole T. Biodefense R & D: anticipating future threats, establishing a strategic environment. Biosecur Bioterror 1 3 (2003) 193-202
8. Jendrek S., Little S.F., Hem S., Mitra G., and Giardina S. Evaluation of the compatibility of a second generation recombinant anthrax vaccine with aluminum-containing adjuvants. Vaccine 21 21-22 (2003) 3011-3018
9. 21. CFR Part 620.20-24, Food and Drug Administration, HHS. Code of Federal Regulations. Subpart C-Anthrax vaccine adsorbed, April 1, 1992; pp. s71-72.
10. Puziss M., and Wright G.G. Studies on immunity in anthrax. X. Gel-adsorbed protective antigen for immunization of man. J Bacteriol 85 (1963) 230-236
11. Kobiler D., Gozes Y., Rosenberg H., and Marcus D. Efficiency of protection of guinea pigs against infection with Bacillus anthracis spores by passive immunization. Infect Immun 70 2 (2002) 544-550
12. Friedlander A.M., Pittman P.R., and Parker G.W. Anthrax vaccine: evidence for safety and efficacy against inhalational anthrax. JAMA 282 22 (1999) 2104-2106
13. Sever J.L., Brenner A.I., Gale A.D., Lyle J.M., Moulton L.H., and West D.J. Safety of anthrax vaccine: a review by the Anthrax Vaccine Expert Committee (AVEC) of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Pharmacoepidemiol Drug Saf 11 3 (2002) 189-202
14. Ivins B.E., Welkos S.L., Little S.F., Crumrine M.H., and Nelson G.O. Immunization against anthrax with Bacillus anthracis protective antigen combined with adjuvants. Infect Immun 60 2 (1992) 662-668
15. Pombo M., Berthold I., Gingrich E., Jaramillo M., Leef M., Sirota L., et al. Validation of an anti-PA-ELISA for the potency testing of anthrax vaccine in mice. Biologicals 32 3 (2004) 157-163
16. Hering D., Thompson W., Hewetson J., Little S., Norris S., and Pace-Templeton J. Validation of the anthrax lethal toxin neutralization assay. Biologicals 32 1 (2004) 17-27
17. Berthold I., Pombo M.L., Wagner L., and Arciniega J.L. Immunogenicity in mice of anthrax recombinant protective antigen in the presence of aluminum adjuvants. Vaccine 23 16 (2005) 1993-1999
18. Reizenstein E., Hallander H.-O., Blackwelder W.C., Kühn I., Ljungman M., and Möllby R. Comparison of five calculation modes for antibody ELISA procedures using pertussis serology as a model. J Immunol Methods 183 2 (1995) 279-290
19. Hansen M.B., Nielsen S.E., and Berg K. Re-examination and further development of a precise and rapid dye method for measuring cell growth/cell kill. J Immunol Methods 119 2 (1989) 203-210
20. Plikaytis B.D., Holder P.F., Pais L.B., Maslanka S.E., Gheesling L.L., and Carlone G.M. Determination of parallelism and nonparallelism in bioassay dilution curves. J Clin Microbiol 32 10 (1994) 2441-2447
21. Bland M.J., and Altman D.G. Measuring agreement in method comparison studies. Stat Methods Med Res 8 2 (1999) 135-160
22. Little S.F., Webster W.M., Ivins B.E., Fellows P.F., Norris S.L., and Andrews G.P. Development of an in vitro-based potency assay for anthrax vaccine. Vaccine 22 21-22 (2004) 2843-2852
23. US Code of Federal Regulations, Title 21, Part 601, Subpart H. April 1, 2008.
24. Omland K.S., Brys A., Lansky D., Clement K., and Lynn F. Participating laboratories. Interlaboratory comparison of results of an anthrax lethal toxin neutralization assay for assessment of functional antibodies in multiple species. Clin Vaccine Immunol 15 6 (2008) 946-953
25. Wisnes R., Sesardic D., Daas A., and Behr-Gross M.E. Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccines-part 2. Pharmeuropa Bio 1 (2006) 73-88
26. Cornbleet P.J., and Gochman N. Incorrect least-squares regression coefficients in method-comparison analysis. Clin Chem 25 3 (1979) 432-438
27. Lin L. A concordance correlation coefficient to evaluate reproducibility. Biometrics 45 1 (1989) 255-268
28. Quinn C.P., Dull P.M., Semenova V., Li H., Crotty S., Taylor T.H., et al. Immune responses to Bacillus anthracis protective antigen in patients with bioterrorism-related cutaneous or inhalation anthrax. J Infect Dis 190 7 (2004) 1228-1236
29. Pittman P.R., Leitman S.F., Barrera-Oro J.G., Norris S.L., Marano N.M., Ranadive M.V., et al. Protective antigen and toxin neutralization antibody patterns in anthrax vaccinees undergoing serial plasmapheresis. Clin Diagn Lab Immunol 12 6 (2005) 713-721
30. Gorse G.J., Keitel W., Keyserling H., Taylor D.N., Lock M., Alves K., et al. Immunogenicity and tolerance of ascending doses of a recombinant protective antigen (rPA102) anthrax vaccine: a randomized, double-blinded, controlled, multicenter trial. Vaccine 24 33-34 (2006) 5950-5959
31. ® anthrax vaccine with the addition of the C-class CpG oligonucleotide adjuvant CPG 10109. Vaccine 25 3 (2007) 526-534
32. Abboud N., and Casadevall A. Immunogenicity of Bacillus anthracis protective antigen domains and efficacy of elicited antibody responses depend on host genetic background. Clin Vaccine Immunol 15 7 (2008) 1115-1123
33. Altman D.G., and Bland J.M. Measurement in medicine: the analysis of method comparison studies. Statistician 32 (1983) 307-317