Immunization against clostridium difficile disease
AssigneeSanofi Pasteur Biologics, LLC
InventorsWilliam D. THOMAS, JR., Paul J. GIANNASCA, Zhenxi ZHANG, Wende LEI, Thomas P. MONATH
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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.
Claims13
A method of producing a Clostridium difficile toxoid, said method comprising the steps of:
- providing a Clostridium difficile bacterium;
- culturing said bacterium in medium lacking animal products to generate a culture;
- purifying clostridial toxin A and clostridial toxin B from said culture to generate a mixture of purified toxins A and B;
- and
- inactivating said purified toxins A and B by incubation in formaldehyde at a temperature of 25° C. or less to generate said clostridial toxoid.
A method of producing human immune globulin directed against a clostridium, said method comprising the steps of:
- administering a clostridial toxin or toxoid to a human;
- and
- isolating said immune globulin against a clostridium from said human.
Clostridium difficile immune globulin produced by administering a Clostridium difficile toxin or toxoid to a human, and isolating said Clostridium difficile immune globulin from said human
A method of identifying a human producing a Clostridium difficile immune globulin, said method comprising the steps of:
- obtaining a blood sample from a human vaccinated with a Clostridium difficile toxoid;
- determining the level of antibodies to Clostridium difficile Toxins A and B in said blood sample by an enzyme-linked immunosorbent assay;
- and
- determining the level of in vitro cytotoxicity neutralization activity against Clostridium difficile Toxins A and B in said blood sample, wherein detection of increased levels of antibodies to Clostridium difficile Toxins A and B in said blood sample, and detection of in vitro cytotoxicity neutralization activity against Clostridium difficile Toxins A and B in said blood sample, indicates identification of a human producing a Clostridium difficile immune globulin useful for treatment or prevention of Clostridium difficile infection.
Dependencies are inferred from the claim text.