Endotoxin content of standardized allergen vaccines

Journal of Allergy and Clinical Immunology

Volumn 111, Issue 4, 2003, Pages 777-783

  Trivedi, Bhavini ^a   Valerio, Cherry ^b   Slater, Jay E ^b  

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

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

Author keywords

Allergen; Allergen immunotherapy; Allergen vaccine; Endotoxin; Endotoxin neutralizing protein; Limulus amebocyte lysate; Lipopolysaccharide; Protease; Standardization

Indexed keywords

ALLERGEN; ALLERGEN VACCINE; BACTERIUM LIPOPOLYSACCHARIDE; BETA 1,3 GLUCAN; CAT HAIR VACCINE; DERMATOPHAGOIDES FARINAE EXTRACT; ENDOTOXIN; ENDOTOXIN NEUTRALIZING PROTEIN; GRASS POLLEN EXTRACT; HOUSE DUST ALLERGEN; PROTEIN; PROTEINASE; RAGWEED POLLEN EXTRACT; RESIN; UNCLASSIFIED DRUG; VACCINE;

ARTICLE; DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; DRUG EFFICACY; DRUG INACTIVATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MIXTURE; DRUG QUALITY; DRUG SAFETY; ENZYME INACTIVATION; GRASS; IMMUNOMODULATION; IMMUNOTHERAPY; INFLAMMATION; LIMULUS LYSATE TEST; PRIORITY JOURNAL; RAGWEED POLLEN; STANDARDIZATION;

EID: 0037393717     PISSN: 00916749     EISSN: None     Source Type: Journal    
DOI: 10.1067/mai.2003.1338     Document Type: Article

References (34)

1. Wolff SM. Biological effects of bacterial endotoxins in man. J Infect Dis 1973;128:259-64.
2. Miller MA, Hjelle JT. Endotoxins and their clinical significance. In: Prior RB, editor. Clinical applications of the Limulus amoebocyte lysate test. Boston: CRC Press; 1990. p. 1-14.
3. Guideline on the validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices. 1987. Available at: http://www.fda.gov/cber/guidelines.htm. Accessed March 13, 2003.
4. Prior RB. The Limulus amoebocyte lysate test. In: Prior RB, editor. Clinical applications of the Limulus amoebocyte lysate test. Boston: CRC Press; 1990. p. 27-36.
5. Siraganian RP, Baer H, Hochstein HD, May JC. Allergenic and biologic activity of commercial preparations of house dust extract. J Allergy Clin Immunol 1979;64:526-33.
6. Smith TF, Morrison DC. Lack of interference in skin tests by endotoxin in allergen extracts. Ann Allergy 1986;57;410-2.
7. 1 antibody formation in mice. Cell Immunol 1976;22:128-39.
8. Slater JE, Paupore EJ, Elwell MR, Truscott W. Lipopolysaccharide augments IgG and IgE responses of mice to the latex allergen Hev b 5. J Allergy Clin Immunol 1998;102:977-83.
9. Liu AH. Endotoxin exposure in allergy and asthma: reconciling a paradox. J Allergy Clin Immunol 2002;109:379-92.
10. Cooper JF, Weary ME, Jordan FT. The impact of non-endotoxin LAL-reactive materials on Limulus amebocyte lysate analyses. PDA J Pharm Sci Technol 1997;51:2-6.
11. Roslansky PF, Novitsky TJ. Sensitivity of Limulus amebocyte lysate (LAL) to LAL-reactive glucans. J Clin Microbiol 1991;29:2477-83.
12. Zhang GH, Baek L, Buchardt O, Koch C. Differential blocking of coagulation-activating pathways of Limulus amebocyte lysate. J Clin Microbiol 1994;32:1537-41.
13. Warren HS, Glennon ML, Wainwright N, Amato SF, Black KM, Kirsch SJ, et al. Binding and neutralization of endotoxin by Limulus antilipopolysaccharide factor. Infect Immunol 1992;60:2506-13.
14. Iraneta SG, Duschak VG, Rodriguez SM, Seoane MA, Albonico JF, Alonso A. Proteinase and gelatinolytic activities of house dust mite and cockroach extracts. J Investig Allergol Clin Immunol 1999;9:235-40.
15. Hewitt CR, Foster S, Phillips C, Horton H, Jones RM, Brown AP, et al. Mite allergens: significance of enzymatic activity. Allergy 1998;53(Suppl 48):60-3.
16. Bagarozzi DA Jr, Travis J. Ragweed pollen proteolytic enzymes: possible roles in allergies and asthma. Phytochemistry 1998;47:593-8.
17. Esch RE. Role of proteases on the stability of allergenic extracts. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 1992;85:171-7.
18. Cooper JF. Evaluation of sterile pharmaceuticals and medical devices: an overview. In: Prior RB, editor. Clinical applications of the Limulus amoebocyte lysate test. Boston: CRC Press; 1990. p. 159-72.
19. Adner N, Flink O, Nystrand R, Pihl B, Vegis P. Collaborative study of a control standard endotoxin using the Limulus amebocyte (gel-clot) test. J Parenter Sci Technol 1991;45:88-93.
20. Garcia C, Saladino R, Thompson C, Hammer B, Parsonnet J, Wainwright N, et al. Effect of a recombinant endotoxin-neutralizing protein on endotoxin shock in rabbits. Crit Care Med 1994;22:1211-8.
21. Hochstein HD. Role of the FDA in regulating the Limulus amoebocyte lysate test. In: Prior RB, editor. Clinical applications of the Limulus amoebocyte lysate test. Boston: CRC Press; 1990. p. 37-50.
22. Tai JY, Seid RC Jr, Huhn RD, Liu TY. Studies on Limulus amoebocyte lysate, II: purification of the coagulogen and the mechanism of clotting. J Biol Chem 1977;252:4773-6.
23. Gehring U, Heinrich J, Jacob B, Richter K, Fahlbusch B, Schlenvoigt G, et al. Respiratory symptoms in relation to indoor exposure to mite and cat allergens and endotoxins: Indoor Factors and Genetics in Asthma (INGA) Study Group. Eur Respir J 2001;18:555-63.
24. Ebner C. Immunological mechanisms operative in allergen-specific immunotherapy. Int Arch Allergy Immunol 1999;119:1-5.
25. H2 response in humans. J Burn Care Rehabil 1996;17:491-6.
26. Reed CE, Milton DK. Endotoxin-stimulated innate immunity: a contributing factor for asthma. J Allergy Clin Immunol 2001;108:157-66.
27. Michel O. Systemic and local airways inflammatory response to endotoxin. Toxicology 2000;152:25-30.
28. Michel O, Nagy A-M, Schroeven M, Duchateau J, Neve J, Fondu P. et al. Dose-response relationship to inhaled endotoxin in normal subjects. Am J Respir Crit Care Med 1997;156:1157-64.
29. Michel O, Kips J, Duchateau J, Vertongen F, Robert L, Collet H, et al. Severity of asthma is related to endotoxin in house dust. Am J Respir Crit Care Med 1996;154:1641-6.
30. Park JH, Gold DR, Spiegelman DL, Burge HA, Milton DK. House dust endotoxin and wheeze in the first year of life. Am J Respir Crit Care Med 2001;163:322-8.
31. Lockey RF, Nicoara-Kasti GL, Theodoropoulos DS, Bukantz SC. Systemic reactions and fatalities associated with allergen immunotherapy. Ann Allergy Asthma Immunol 2001;87:47-55.
32. Ragusa FV, Passalacqua G, Gambardella R, Campanari S, Barbieri MM, Scordamaglia A, et al. Nonfatal systemic reactions to subcutaneous immunotherapy: a 10-year experience. J Investig Allergol Clin Immunol 1997;7:151-4.
33. Bacterial endotoxins test. United States Pharmacopeia. Rockville, Md: United States Pharmacopeial Convention, Inc, 1994. p. 1696-7.
34. Michie HR, Manogue KR, Spriggs DR, Revhaug A, O'Dwyer S, Dinarello CA, et al. Detection of circulating tumor necrosis factor after endotoxin administration. N Engl J Med 1988;318:1481-6.