Evaluation of endotoxin content of diphtheria-tetanus-acellular pertussis combined (DTaP) vaccines that interfere with the bacterial endotoxin test

Vaccine

Volumn 21, Issue 17-18, 2003, Pages 1862-1866

  Ochiai, Masaki ^a   Kataoka, Michiyo ^a   Toyoizumi, Hiromi ^a   Kamachi, Kazunari ^a   Yamamoto, Akihiko ^a   Horiuchi, Yoshinobu ^a  

^a NATIONAL INSTITUTE OF INFECTIOUS DISEASES   (Japan)

Author keywords

DTP vaccine; Endotoxin; Pyrogen

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS VACCINE; ENDOTOXIN; GALACTOSAMINE; PHOSPHATE; TUMOR NECROSIS FACTOR ALPHA;

ANIMAL EXPERIMENT; ARTICLE; ASSAY; CONTROLLED STUDY; DIPHTHERIA; DRUG ACTIVITY; ENZYME ACTIVITY; FEMALE; IN VITRO STUDY; LIMULUS LYSATE TEST; MOUSE; NONHUMAN; PERTUSSIS; PRIORITY JOURNAL; RANDOMIZATION; TETANUS;

EID: 0037449058     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0264-410X(03)00006-9     Document Type: Article

References (18)

1. Sasaki S. Biological activity of lipopolysaccharides isolated from bacteria in human periodontal lesions. Bull. Tokyo Dent. Coll. 20(4):1979;159-174.
2. Grisman S.E., Hornick R.B. Comparative pyrogenic reactivity of rabbit and man to bacterial endotoxin. Proc. Soc. Exp. Biol. Med. 131:1969;1154-1158.
3. Minimum requirements for biological products. Japan: Ministry of Health and Welfare, Japanese Government; 1993.
4. Kimura M., Kuno-Sakai H. Experiences with acellular pertussis vaccine in Japan and epidemiology of pertussis. Tokai J. Exp. Clin. Med. 12(5-6):1987;263-273.
5. Levin J., Bang F.B. The role of endotoxin in the extracellular coagulation of Limulus blood. Bull. Johns Hopkins Hosp. 115:1964;265-274.
6. Tanaka S., Iwanaga S. Limulus test for detecting bacterial endotoxins. Methods Enzymol. 223:1993;358-364.
7. Tsuchiya M., Takaoka A., Tokioka N., Matsuura S. Development of an endotoxin-specific Limulus amebocyte lysate test blocking beta-glucan-mediated pathway by carboxymethylated curdlan and its application. J. Pharm. Soc. Jpn. 45(6):1990;903-911.
8. US pharmacopoeia. Bacterial endotoxin test. 25th ed. 2002.
9. European pharmacopoeia. Supplement. 3rd ed. 2000.
10. Japanese pharmacopoeia. 14th ed. 2001.
11. Guidelines for the production and control of the acellular pertussis component of monovalent or combined vaccines. WHO Tech. Rep. Ser. 1998;878:57-76.
12. Ochiai M., Yamamoto A., Kataoka M., Toyoizumi H., Horiuchi Y. Interfering effect of diphtheria-tetanus-acellular pertussis combined (DTaP) vaccines on the bacterial endotoxin test. Biologicals. 29:2001;55-58.
13. Ochiai M., Kataoka M., Toyoizumi H., Yamamoto A., Horiuchi Y. A quantitative in vitro assay for detecting biological activity of endotoxin using peripheral blood of rabbits. Jpn. J. Infect. Dis. 54:2001;131-136.
14. Westphal O, Jann K. In: Whistler RL, editor. Methods in carbohydrate chemistry, vol. V. New York: Academic Press; 1965. p. 83.
15. Murai T., Nakagawa Y., Miyawaki E., Ogawa Y., Horiuchi Y. The endotoxin reference standard of the National Institute of Health Sciences (the Japanese pharmacopoeia endotoxin reference standard) (control 971). Bull. Natl. Inst. Health Sci. 115:1997;202-203.
16. Morita T., Tanaka S., Nakamura T., Iwanaga S. A new (1-3)-β-D-glucan-mediated coagulation pathway found in Limulus amebocytes. FEBS Lett. 129:1981;318-321.
17. Finney DJ. Statistical methods in biological assay. 3rd ed. London: Charles Griffin; 1978.
18. Freudenberg M.A., Keppler D., Galanos C. Requirement for lipopolysaccharide-responsive macrophages in galactosamine-induced sensitization to endotoxin. Infect. Immun. 51(3):1986;891-895.