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J Allergy Clin Immunol. 2003 Apr;111(4):777-83.

Endotoxin content of standardized allergen vaccines.

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  • 1National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md, USA.

Abstract

BACKGROUND:

Endotoxin is a ubiquitous and potent proinflammatory agent. Previous limited studies suggest that it is pres-ent in allergen vaccines and that this could affect the safety and efficacy of allergen immunotherapy. The endotoxin content of standardized allergen vaccines is unknown.

OBJECTIVE:

The purpose of this study was to quantify the amount of endotoxin contained in standardized allergen vaccines.

METHODS:

The endotoxin content of 14 allergen vaccines was measured by using the Limulus amebocyte lysate (LAL) gel-clot assay. To account for (1,3)-beta-d-glucan and protease interference, vaccines were selectively depleted of endotoxin and then retested with the gel-clot assay. Proteases were also heat-inactivated in selected vaccines. Fifty-eight lots of vaccines were tested, including at least two manufacturers per vaccine.

RESULTS:

The endotoxin content of the 58 vaccines ranged from undetectable to 34,000 EU/mL. Cat pelt (12,735 EU/mL; range, 5177 to 33,805) had significantly more endotoxin activity than cat hair (2883 EU/mL; range, 1 to 16,962), and Dermatophagoides farinae extracts (4619 EU/mL; range, 849 to 8485) had more than Dermatophagoides pteronyssinus (11 EU/mL; range, 1 to 34). Grass (160 EU/mL; range, 3 to 1561) and ragweed pollen (341 EU/mL; range, 8 to 1697) vaccines contained less endotoxin. (1,3)-beta-d-glucan interference was significant (>10%) only in three ragweed vaccines and two grass vaccines. Heat inactivation had no effect. There were considerable differences in endotoxin content of the same vaccines made by different manufacturers.

CONCLUSIONS:

The endotoxin content of standardized allergen vaccines is extremely variable. Interference by proteases and (1,3)-beta-d-glucans is minimal. The effects of the high levels of endotoxin in some vaccines on the immunomodulatory changes associated with allergen immunotherapy require further study.

PMID:
12704357
[PubMed - indexed for MEDLINE]
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