Evaluation of endotoxin content of diphtheria-tetanus-acellular pertussis combined (DTaP) vaccines that interfere with the bacterial endotoxin test.
Applicability of the endotoxin test to diphtheria-tetanus-acellular pertussis combined (DTaP) vaccines was examined. We found some DTaP vaccines that strongly interfered with Limulus amoebocyte lysate (LAL) activity of endotoxin without affecting lethal activity of endotoxin in D-galactosamine-treated mice. LAL activity that was interfered in such vaccines increased apparently after the treatment with phosphate buffer at 4 degrees C for a week. The DTaP vaccines that interfered with the endotoxin test showed no significant effect on endotoxin activity in inducing tumor necrosis factor-alpha (TNF-alpha) in rabbit peripheral blood. The in vitro TNF-alpha induction assay was, therefore, suggested to be an appropriate assay method for the quantitative detection of the endotoxin activity in DTaP vaccines.
Ochiai
Masaki
M
Department of Bacterial Pathogenesis and Infection Control, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama, Tokyo 208-0011, Japan. masakio@nih.go.jp
Kataoka
Michiyo
M
Toyoizumi
Hiromi
H
Kamachi
Kazunari
K
Yamamoto
Akihiko
A
Horiuchi
Yoshinobu
Y
D000818:Animals; D001426:Bacterial Proteins / Q000032:analysis*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000737:chemistry* / Q000633:toxicity*; D004731:Endotoxins / Q000032:analysis*; D008070:Lipopolysaccharides / Q000032:analysis; D051379:Mice; D011817:Rabbits; D015203:Reproducibility of Results
D001426:Bacterial Proteins; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D004731:Endotoxins; D008070:Lipopolysaccharides