Phase I study of intradermal immunotherapy with oil-attached Mycobacterium smegmatis cell wall skeleton and trehalose dimycolate |
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| Authors: | G Vosika J Schmidtke Anne Goldman R Parker E Ribi G R Gray |
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| Institution: | (1) From the Department of Medicine of the University of Minnesota, 55455 Minneapolis, Minnesota, USA;(2) Department of Surgery of the University of Minnesota, 55455 Minneapolis, Minnesota, USA;(3) Department of Chemistry of the University of Minnesota, 55455 Minneapolis, Minnesota, USA;(4) Division of Biometry of the University of Minnesota, 55455 Minneapolis, Minnesota, USA;(5) Hamilton Biochemical Inc., 59840 Hamilton, Montana, USA;(6) Rocky Mountain Laboratory of the NIAID, 59840 Hamilton, Montana, USA |
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| Abstract: | Summary The clinical toxicity of intradermal immunotherapy with a nonviable mycobacterial vaccine consisting of oil-attached Mycobacterium smegmatis cell wall skeleton (CWS) and trehalose dimycolate (P3) was evaluated. Fifteen patients with advanced hypernephroma, lung cancer, or malignant melanoma were evaluated. Patients received one to ten separate intradermal injections in the subclavicular areas weekly for up to 8 weeks. Each separate injection usually contained 75  g CWS and 37.5 g P3.There were few systemic side effects. Mild fever occurred in 30% of 69 treatments. Severe local toxicity with ulceration and/or abscess formation occurred in seven patients. Regression of disease was observed in one patient to occur on two separate occasions following separate courses of therapy.Although intradermal CWS/P3 can be locally toxic, treatment with up to four separate injections of 75 g CWS combined with 37.5 g P3 every 1–2 weeks appears appropriate, from this study, for additional clinical trials. |
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