Immunization against clostridium difficile disease

Abstract

The invention provides active and passive immunization methods for preventing and treating Clostridium difficile infection, which involve percutaneous administration of C. difficile toxin-neutralizing polyclonal immune globulin, C. difficile toxoids, or combinations thereof. Also provided by the invention are C. difficile toxoids, C. difficile toxin-neutralizing polyclonal immune globulin, and methods of identifying subjects that produce C. difficile toxin-neutralizing polyclonal immune globulin.

Description

[0001] This is a continuation of U.S. Ser. No. 10 / 737,270, filed Dec. 16, 2003 (pending), which is a continuation-in-part of U.S. Ser. No. 09 / 815,452, filed Mar. 22, 2001 (U.S. Pat. No. 6,680,168), which is a continuation of U.S. Ser. No. 09 / 176,076, filed Oct. 20, 1998 (U.S. Pat. No. 6,214,341 B1), which claims priority from U.S. Ser. No. 60 / 062,522, filed on Oct. 20, 1997 (abandoned).BACKGROUND OF THE INVENTION [0002] This invention relates to methods and compositions for preventing and treating Clostridium difficile disease. [0003]Clostridium difficile, a toxin-producing Gram-positive bacterium, invades the intestinal tracts of patients whose normal intestinal flora is suppressed due to treatment with broad-spectrum antibiotics. The bacterial toxins cause varying degrees of damage to the large intestinal (i.e., colonic) epithelium, and cause a spectrum of illnesses, ranging from mild diarrhea to severe colitis. Because antibiotic treatment induces the onset of C. difficile diseas...

AI Technical Summary

Benefits of technology

"The patent describes methods for treating and preventing Clostridium difficile disease in humans by administering a polyclonal immune globulin that neutralizes both Toxin A and Toxin B. The immune globulin can be percutaneously administered to patients and can also be produced by culturing C. difficile bacteria and co-purifying the toxins. The methods can involve mucosal administration, such as oral or rectal, and can also include the use of an adjuvant. The patent also describes methods for identifying individuals who produce the immune globulin. Overall, the patent provides methods for protecting against C. difficile disease and preventing its recurrence."

Problems solved by technology

Both toxins are lethal to animals when administered systemically.

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